Trial Outcomes & Findings for A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers (NCT NCT00762359)
NCT ID: NCT00762359
Last Updated: 2012-02-03
Results Overview
The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
461 participants
Primary outcome timeframe
18 Months
Results posted on
2012-02-03
Participant Flow
Participants were enrolled at sites in Japan from May 2007 to November 2008.
Participants were enrolled in either lansoprazole, once daily (QD) or gefarnate, twice daily (BID) treatment groups.
Participant milestones
| Measure |
Lansoprazole 15 mg QD
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Overall Study
STARTED
|
226
|
235
|
|
Overall Study
COMPLETED
|
167
|
178
|
|
Overall Study
NOT COMPLETED
|
59
|
57
|
Reasons for withdrawal
| Measure |
Lansoprazole 15 mg QD
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
20
|
23
|
|
Overall Study
Protocol Violation
|
21
|
13
|
|
Overall Study
Withdrawal by Subject
|
13
|
10
|
|
Overall Study
Lack of Efficacy
|
0
|
4
|
|
Overall Study
Institution closed
|
2
|
3
|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Removal
|
0
|
1
|
|
Overall Study
Withdrew consent
|
1
|
0
|
Baseline Characteristics
A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers
Baseline characteristics by cohort
| Measure |
Lansoprazole 15 mg QD
n=226 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=235 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
Total
n=461 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=39 years
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Age, Customized
Between 40 and 49 years
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Age, Customized
Between 50 and 59 years
|
31 participants
n=99 Participants
|
36 participants
n=107 Participants
|
67 participants
n=206 Participants
|
|
Age, Customized
Between 60 and 64 years
|
28 participants
n=99 Participants
|
32 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Age, Customized
Between 65 and 69 years
|
38 participants
n=99 Participants
|
53 participants
n=107 Participants
|
91 participants
n=206 Participants
|
|
Age, Customized
Between 70 and 79 years
|
105 participants
n=99 Participants
|
81 participants
n=107 Participants
|
186 participants
n=206 Participants
|
|
Age, Customized
<=80 years
|
22 participants
n=99 Participants
|
29 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
175 Participants
n=99 Participants
|
192 Participants
n=107 Participants
|
367 Participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
226 participants
n=99 Participants
|
235 participants
n=107 Participants
|
461 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 18 MonthsPopulation: Participants not taking investigational drug were not included.
The number of participants that developed gastric ulcer and/or duodenal ulcer at month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=226 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=234 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Number of Participants With Gastric Ulcer and/or Duodenal Ulcer
|
6 participants
|
53 participants
|
SECONDARY outcome
Timeframe: Baseline and Month 3.Population: Values are from the Full Analysis Set.
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=213 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=215 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
|
-0.150 scores on a scale
Standard Deviation 0.904
|
0.460 scores on a scale
Standard Deviation 1.241
|
SECONDARY outcome
Timeframe: Baseline and Month 6.Population: Values are from the Full Analysis Set.
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=170 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=134 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
|
-0.153 scores on a scale
Standard Deviation 1.172
|
0.530 scores on a scale
Standard Deviation 1.444
|
SECONDARY outcome
Timeframe: Baseline and Month 9.Population: Values are from the Full Analysis Set.
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=87 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=74 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)
|
-0.149 scores on a scale
Standard Deviation 1.157
|
0.419 scores on a scale
Standard Deviation 1.375
|
SECONDARY outcome
Timeframe: Baseline and Month 12.Population: Values are from the Full Analysis Set.
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=67 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=44 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Gastric Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
|
-0.224 scores on a scale
Standard Deviation 1.112
|
0.205 scores on a scale
Standard Deviation 1.047
|
SECONDARY outcome
Timeframe: Baseline and Month 18.Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the stomach, graded on a 5 point scale (0=normal; 1= erosion/hemorrhage in one area of the stomach and \<1 lesion; 2= erosion/hemorrhage in one area of the stomach with 2-5 lesions; 3= erosion/hemorrhage in two areas in the stomach/one area involves \>6 lesions; 4= erosion/hemorrhage appear in three or more areas in the stomach). Erosions are mucosal defect \< 3 mm. Ulcers are mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of gastric mucosal injury.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Month 3.Population: Values are from the Full Analysis Set.
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=212 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=215 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 3)
|
-0.132 scores on a scale
Standard Deviation 0.552
|
0.228 scores on a scale
Standard Deviation 0.755
|
SECONDARY outcome
Timeframe: Baseline and Month 6.Population: Values are from the Full Analysis Set.
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=170 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=134 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 6)
|
-0.165 scores on a scale
Standard Deviation 0.583
|
0.149 scores on a scale
Standard Deviation 0.741
|
SECONDARY outcome
Timeframe: Baseline and Month 9.Population: Values are from the Full Analysis Set.
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=87 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=74 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 9)
|
-0.092 scores on a scale
Standard Deviation 0.542
|
0.216 scores on a scale
Standard Deviation 0.688
|
SECONDARY outcome
Timeframe: Baseline and Month 12.Population: Values are from the Full Analysis Set.
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=67 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=44 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Duodenal Mucosal Injury Assessed by Lanza Score (Partially Revised) (Month 12)
|
-0.254 scores on a scale
Standard Deviation 0.766
|
0.136 scores on a scale
Standard Deviation 0.409
|
SECONDARY outcome
Timeframe: Baseline and Month 18.Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
The Lanza score (partially revised) attributes the severity of induced erosive mucosal injury in the duodenum, graded on a 4 point scale (0=normal; 1= erosion and hemorrhage are localized in one area of the duodenum and \< 1 lesion; 2= 2 to 5 lesions ; 3= \> 6 lesions). Erosions are defined as mucosal defect \< 3 mm. Ulcers are defined as mucosal defect with white coating ≥ 3 mm. Higher scores indicate greater severity of duodenal mucosal injury.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 MonthsPopulation: Values are from the Full Analysis Set.
Number of participants with gastric or duodenal ulcer or gastric or duodenal hemorrhagic lesion (upper gastrointestinal hemorrhage) from baseline through month 18 or final visit. Ulcers are defined as mucosal defect with white coating 3 mm or greater.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=226 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=234 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Number of Participants With Gastric or Duodenal Ulcer or Gastric or Duodenal Hemorrhagic Lesion (Upper Gastrointestinal Hemorrhage)
|
7 participants
|
56 participants
|
SECONDARY outcome
Timeframe: Baseline and Month 3.Population: Values are from the Full Analysis Set.
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=202 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=196 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 3)
|
-0.005 scores on a scale
Standard Deviation 0.187
|
0.015 scores on a scale
Standard Deviation 0.295
|
SECONDARY outcome
Timeframe: Baseline and Month 6.Population: Values are from the Full Analysis Set.
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=158 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=133 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 6)
|
-0.025 scores on a scale
Standard Deviation 0.158
|
-0.030 scores on a scale
Standard Deviation 0.171
|
SECONDARY outcome
Timeframe: Baseline and Month 9.Population: Values are from the Full Analysis Set.
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=111 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=86 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 9)
|
-0.027 scores on a scale
Standard Deviation 0.163
|
-0.023 scores on a scale
Standard Deviation 0.152
|
SECONDARY outcome
Timeframe: Baseline and Month 12.Population: Values are from the Full Analysis Set.
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=49 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=28 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 12)
|
-0.020 scores on a scale
Standard Deviation 0.143
|
-0.071 scores on a scale
Standard Deviation 0.262
|
SECONDARY outcome
Timeframe: Baseline and Month 18.Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Postprandial pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=3 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=1 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Postprandial Pain Gastrointestinal Symptom (Month 18)
|
-0.333 scores on a scale
Standard Deviation 0.577
|
-1.000 scores on a scale
Standard Deviation NA
No test was performed when the number of cases was 5 or less.
|
SECONDARY outcome
Timeframe: Baseline and Month 3.Population: Values are from the Full Analysis Set.
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=202 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=196 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 3)
|
0.005 scores on a scale
Standard Deviation 0.307
|
0.026 scores on a scale
Standard Deviation 0.357
|
SECONDARY outcome
Timeframe: Baseline and Month 6.Population: Values are from the Full Analysis Set.
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=158 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=133 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 6)
|
-0.038 scores on a scale
Standard Deviation 0.192
|
-0.008 scores on a scale
Standard Deviation 0.261
|
SECONDARY outcome
Timeframe: Baseline and Month 9.Population: Values are from the Full Analysis Set.
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=111 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=86 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 9)
|
-0.027 scores on a scale
Standard Deviation 0.211
|
-0.023 scores on a scale
Standard Deviation 0.152
|
SECONDARY outcome
Timeframe: Baseline and Month 12.Population: Values are from the Full Analysis Set.
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=49 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=28 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 12)
|
0.000 scores on a scale
Standard Deviation 0.204
|
-0.071 scores on a scale
Standard Deviation 0.262
|
SECONDARY outcome
Timeframe: Baseline and Month 18.Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Hunger and nighttime pain is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=3 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=1 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Hunger and Nighttime Pain Gastrointestinal Symptom (Month 18)
|
-0.333 scores on a scale
Standard Deviation 0.577
|
-1.000 scores on a scale
Standard Deviation NA
No test was performed when the number of cases was 5 or less.
|
SECONDARY outcome
Timeframe: Baseline and Month 3.Population: Values are from the Full Analysis Set.
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=202 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=196 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 3)
|
-0.020 scores on a scale
Standard Deviation 0.315
|
-0.005 scores on a scale
Standard Deviation 0.312
|
SECONDARY outcome
Timeframe: Baseline and Month 6.Population: Values are from the Full Analysis Set.
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=158 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=133 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 6)
|
-0.019 scores on a scale
Standard Deviation 0.329
|
0.015 scores on a scale
Standard Deviation 0.325
|
SECONDARY outcome
Timeframe: Baseline and Month 9.Population: Values are from the Full Analysis Set.
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=111 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=86 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 9)
|
-0.027 scores on a scale
Standard Deviation 0.368
|
-0.023 scores on a scale
Standard Deviation 0.265
|
SECONDARY outcome
Timeframe: Baseline and Month 12.Population: Values are from the Full Analysis Set.
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=49 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=28 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 12)
|
-0.020 scores on a scale
Standard Deviation 0.143
|
-0.036 scores on a scale
Standard Deviation 0.331
|
SECONDARY outcome
Timeframe: Baseline and Month 18.Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Feeling of enlarged abdomen is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=3 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=1 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Enlarged Abdomen Gastrointestinal Symptom (Month 18)
|
NA scores on a scale
Standard Deviation NA
No test was performed when the number of cases was 5 or less.
|
NA scores on a scale
Standard Deviation NA
No test was performed when the number of cases was 5 or less.
|
SECONDARY outcome
Timeframe: Baseline and Month 3.Population: Values are from the Full Analysis Set.
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=202 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=196 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 3)
|
-0.025 scores on a scale
Standard Deviation 0.233
|
0.020 scores on a scale
Standard Deviation 0.142
|
SECONDARY outcome
Timeframe: Baseline and Month 6.Population: Values are from the Full Analysis Set.
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=158 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=133 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 6)
|
-0.051 scores on a scale
Standard Deviation 0.220
|
0.008 scores on a scale
Standard Deviation 0.087
|
SECONDARY outcome
Timeframe: Baseline and Month 9.Population: Values are from the Full Analysis Set.
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=111 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=86 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 9)
|
-0.072 scores on a scale
Standard Deviation 0.260
|
0.012 scores on a scale
Standard Deviation 0.108
|
SECONDARY outcome
Timeframe: Baseline and Month 12.Population: Values are from the Full Analysis Set.
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=49 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=28 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 12)
|
-0.082 scores on a scale
Standard Deviation 0.277
|
0.000 scores on a scale
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline and Month 18.Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Feeling of nausea is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=3 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=1 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Nausea Gastrointestinal Symptom (Month 18)
|
NA scores on a scale
Standard Deviation NA
No test was performed when the number of cases was 5 or less.
|
NA scores on a scale
Standard Deviation NA
No test was performed when the number of cases was 5 or less.
|
SECONDARY outcome
Timeframe: Baseline and Month 3.Population: Values are from the Full Analysis Set.
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=202 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=196 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 3)
|
-0.064 scores on a scale
Standard Deviation 0.387
|
-0.005 scores on a scale
Standard Deviation 0.411
|
SECONDARY outcome
Timeframe: Baseline and Month 6.Population: Values are from the Full Analysis Set.
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=158 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=133 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 6)
|
-0.089 scores on a scale
Standard Deviation 0.346
|
0.038 scores on a scale
Standard Deviation 0.451
|
SECONDARY outcome
Timeframe: Baseline and Month 9.Population: Values are from the Full Analysis Set.
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=111 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=86 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 9)
|
-0.063 scores on a scale
Standard Deviation 0.411
|
0.000 scores on a scale
Standard Deviation 0.376
|
SECONDARY outcome
Timeframe: Baseline and Month 12.Population: Values are from the Full Analysis Set.
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=49 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=28 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 12)
|
-0.163 scores on a scale
Standard Deviation 0.373
|
-0.036 scores on a scale
Standard Deviation 0.331
|
SECONDARY outcome
Timeframe: Baseline and Month 18.Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Feeling of heartburn is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=3 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=1 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Feeling of Heartburn Gastrointestinal Symptom (Month 18)
|
NA scores on a scale
Standard Deviation NA
No test was performed when the number of cases was 5 or less.
|
NA scores on a scale
Standard Deviation NA
No test was performed when the number of cases was 5 or less.
|
SECONDARY outcome
Timeframe: Baseline and Month 3.Population: Values are from the Full Analysis Set.
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=202 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=196 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 3)
|
0.005 scores on a scale
Standard Deviation 0.254
|
0.010 scores on a scale
Standard Deviation 0.175
|
SECONDARY outcome
Timeframe: Baseline and Month 6.Population: Values are from the Full Analysis Set.
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=158 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=133 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 6)
|
-0.019 scores on a scale
Standard Deviation 0.177
|
0.000 scores on a scale
Standard Deviation 0.246
|
SECONDARY outcome
Timeframe: Baseline and Month 9.Population: Values are from the Full Analysis Set.
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=111 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=86 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 9)
|
-0.018 scores on a scale
Standard Deviation 0.190
|
0.000 scores on a scale
Standard Deviation 0.153
|
SECONDARY outcome
Timeframe: Baseline and Month 12.Population: Values are from the Full Analysis Set.
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=49 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=28 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 12)
|
0.000 scores on a scale
Standard Deviation 0.204
|
-0.036 scores on a scale
Standard Deviation 0.189
|
SECONDARY outcome
Timeframe: Baseline and Month 18.Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Severity of anorexia is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=3 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=1 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Anorexia Gastrointestinal Symptom (Month 18)
|
-0.333 scores on a scale
Standard Deviation 0.577
|
NA scores on a scale
Standard Deviation NA
No test was performed when the number of cases was 5 or less.
|
SECONDARY outcome
Timeframe: Baseline and Month 3.Population: Values are from the Full Analysis Set.
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=202 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=196 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 3)
|
-0.010 scores on a scale
Standard Deviation 0.099
|
0.020 scores on a scale
Standard Deviation 0.286
|
SECONDARY outcome
Timeframe: Baseline and Month 6.Population: Values are from the Full Analysis Set.
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=158 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=133 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 6)
|
-0.006 scores on a scale
Standard Deviation 0.138
|
0.000 scores on a scale
Standard Deviation 0.123
|
SECONDARY outcome
Timeframe: Baseline and Month 9.Population: Values are from the Full Analysis Set.
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=111 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=86 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 9)
|
-0.009 scores on a scale
Standard Deviation 0.165
|
-0.012 scores on a scale
Standard Deviation 0.108
|
SECONDARY outcome
Timeframe: Baseline and Month 12.Population: Values are from the Full Analysis Set.
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=49 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=28 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 12)
|
-0.020 scores on a scale
Standard Deviation 0.143
|
0.000 scores on a scale
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: Baseline and Month 18.Population: No test was performed when the number of cases was 5 or less. Values are from the Full Analysis Set.
Severity of hematemesis and melena (blood stool, black stool, tarry stool) is graded on a 4 point scale (0=none; 1=mild; 2=moderate; 3=severe). Higher scores indicate greater severity of gastrointestinal symptom.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=3 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=1 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Change From Baseline in Severity of Hematemesis and Melena Gastrointestinal Symptom (Month 18)
|
NA scores on a scale
Standard Deviation NA
No test was performed when the number of cases was 5 or less.
|
NA scores on a scale
Standard Deviation NA
No test was performed when the number of cases was 5 or less.
|
SECONDARY outcome
Timeframe: 18 MonthsTreatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug. A TEAE may also be a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. Please see Other Adverse Events table below for TEAE listings.
Outcome measures
| Measure |
Lansoprazole 15 mg QD
n=226 Participants
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=234 Participants
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Number of Participants With Adverse Events
Adverse event
|
166 participants
|
168 participants
|
|
Number of Participants With Adverse Events
Adverse event (Frequency ≥5%)
|
82 participants
|
68 participants
|
|
Number of Participants With Adverse Events
Adverse event related to the study drug
|
26 participants
|
25 participants
|
|
Number of Participants With Adverse Events
Serious adverse event
|
27 participants
|
26 participants
|
|
Number of Participants With Adverse Events
Serious adverse event related to the study drug
|
0 participants
|
1 participants
|
Adverse Events
Lansoprazole 15 mg QD
Serious events: 27 serious events
Other events: 82 other events
Deaths: 0 deaths
Gefarnate 50 mg BID
Serious events: 26 serious events
Other events: 68 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lansoprazole 15 mg QD
n=226 participants at risk
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=234 participants at risk
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Gastrointestinal disorders
Colonic polyp
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.85%
2/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Cataract
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Corneal degeneration
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.88%
2/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Angina pectoris
|
1.8%
4/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.3%
3/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.85%
2/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hemiplegia
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest discomfort
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Cyst
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.88%
2/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer stage unspecified
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.00%
0/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.43%
1/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.44%
1/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Lansoprazole 15 mg QD
n=226 participants at risk
Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.
|
Gefarnate 50 mg BID
n=234 participants at risk
Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.2%
14/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.4%
8/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.4%
19/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.85%
2/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
1.3%
3/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.8%
16/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
22.6%
51/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
19.2%
45/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
5.8%
13/226 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.8%
9/234 • Adverse events were summarized by onset date occurring on or after the first dose of double-blind study medication.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Sr. VP Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.
- Publication restrictions are in place
Restriction type: OTHER