Trial Outcomes & Findings for Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn (NCT NCT00255190)
NCT ID: NCT00255190
Last Updated: 2016-07-27
Results Overview
COMPLETED
PHASE3
591 participants
Baseline and Month 12
2016-07-27
Participant Flow
Subjects were enrolled at 104 sites in the United States from 07 January 2006 to 25 June 2008.
At screening, subjects completed a Patient Assessment of Upper Gastrointestinal Disorders Quality-of-Life Index (PAGI-QOL) and Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) questionnaires before enrollment in Dexlansoprazole Modified Release (MR) 60 mg or 90 mg once daily (QD) treatment groups.
Participant milestones
| Measure |
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
438
|
|
Overall Study
COMPLETED
|
103
|
281
|
|
Overall Study
NOT COMPLETED
|
50
|
157
|
Reasons for withdrawal
| Measure |
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Overall Study
Adverse Event
|
17
|
36
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
10
|
27
|
|
Overall Study
Withdrew Consent
|
17
|
48
|
|
Overall Study
Inclusion/Exclusion criteria not met
|
0
|
1
|
|
Overall Study
Erosive esophagitis not healed
|
0
|
20
|
|
Overall Study
Various
|
4
|
23
|
Baseline Characteristics
Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Baseline characteristics by cohort
| Measure |
Dexlansoprazole MR 60 mg QD
n=153 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=438 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
Total
n=591 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
45 to <65 years
|
71 subjects
n=99 Participants
|
237 subjects
n=107 Participants
|
308 subjects
n=206 Participants
|
|
Age, Customized
≥65 years
|
17 subjects
n=99 Participants
|
43 subjects
n=107 Participants
|
60 subjects
n=206 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=99 Participants
|
283 Participants
n=107 Participants
|
388 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
203 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 subjects
n=99 Participants
|
8 subjects
n=107 Participants
|
11 subjects
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 subjects
n=99 Participants
|
14 subjects
n=107 Participants
|
20 subjects
n=206 Participants
|
|
Race/Ethnicity, Customized
Black of African Heritage
|
18 subjects
n=99 Participants
|
44 subjects
n=107 Participants
|
62 subjects
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
126 subjects
n=99 Participants
|
366 subjects
n=107 Participants
|
492 subjects
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 subjects
n=99 Participants
|
6 subjects
n=107 Participants
|
6 subjects
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 13.78 • n=99 Participants
|
49.0 years
STANDARD_DEVIATION 13.50 • n=107 Participants
|
48.7 years
STANDARD_DEVIATION 13.57 • n=206 Participants
|
|
Age, Customized
<45 years
|
65 subjects
n=99 Participants
|
158 subjects
n=107 Participants
|
223 subjects
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
129 Participants
n=99 Participants
|
374 Participants
n=107 Participants
|
503 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
153 subjects
n=99 Participants
|
438 subjects
n=107 Participants
|
591 subjects
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=88 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=228 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Hemoglobin Values
|
-0.29 g/dL
Standard Deviation 0.873
|
-0.05 g/dL
Standard Deviation 0.959
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Hematocrit measurement percent is the absolute difference in Hematocrit values, and not percentage difference.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=88 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=228 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Hematocrit Values
|
-1.98 percentage
Standard Deviation 2.573
|
-0.93 percentage
Standard Deviation 3.156
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=88 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=228 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Red Blood Cell Count Values
|
-0.31 Red Blood Cell count x10 to the 6/μL
Standard Deviation 0.271
|
-0.11 Red Blood Cell count x10 to the 6/μL
Standard Deviation 0.349
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=88 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=228 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Mean Corpuscular Hemoglobin Concentration Values
|
0.67 g/dL
Standard Deviation 1.428
|
0.56 g/dL
Standard Deviation 1.277
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=88 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=224 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Platelet Count Values
|
-12.7 Platelet Count x10 to the 3/mcL
Standard Deviation 36.24
|
-1.9 Platelet Count x10 to the 3/mcL
Standard Deviation 39.31
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=88 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=228 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for White Blood Cell Count Values
|
-0.20 White Blood Cell count x10 to the 3/mcL
Standard Deviation 1.610
|
0.04 White Blood Cell count x10 to the 3/mcL
Standard Deviation 1.624
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=89 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=232 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Blood Urea Nitrogen Values
|
0.1 mg/dL
Standard Deviation 4.58
|
0.0 mg/dL
Standard Deviation 4.03
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=89 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=232 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Creatinine Values
|
-0.04 mg/dL
Standard Deviation 0.323
|
-0.04 mg/dL
Standard Deviation 0.111
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=89 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=232 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Calcium Values
|
-0.25 mg/dL
Standard Deviation 0.421
|
-0.04 mg/dL
Standard Deviation 0.443
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=89 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=231 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Inorganic Phosphorus Values
|
0.09 mg/dL
Standard Deviation 0.613
|
0.06 mg/dL
Standard Deviation 0.730
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=89 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=231 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Total Bilirubin Values
|
-0.02 mg/dL
Standard Deviation 0.166
|
-0.01 mg/dL
Standard Deviation 0.170
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=89 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=231 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Alkaline Phosphatase Values
|
0.4 U/L
Standard Deviation 11.59
|
-0.4 U/L
Standard Deviation 14.69
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=88 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=221 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Aspartate Aminotransferase Values
|
0.9 U/L
Standard Deviation 7.81
|
0.6 U/L
Standard Deviation 10.14
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=89 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=226 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Alanine Aminotransferase Values
|
1.6 U/L
Standard Deviation 10.43
|
0.5 U/L
Standard Deviation 17.43
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=81 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=208 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Serum Gastrin Levels
|
155.8 pg/mL
Standard Deviation 189.67
|
115.4 pg/mL
Standard Deviation 156.32
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=88 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=237 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Systolic Blood Pressure
|
3.8 mm Hg
Standard Deviation 15.37
|
1.9 mm Hg
Standard Deviation 14.91
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=88 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=237 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Diastolic Blood Pressure
|
4.0 mm Hg
Standard Deviation 9.53
|
0.6 mm Hg
Standard Deviation 11.03
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug are included in safety analyses. For changes from baseline, a subject had to have a baseline value and a Month 12 value to be included in the summary of a specific parameter.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=88 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=237 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for Pulse Rate
|
0.5 beats per minute
Standard Deviation 10.11
|
-1.3 beats per minute
Standard Deviation 11.87
|
PRIMARY outcome
Timeframe: Baseline and Final Visit (up to 12 months)Population: All subjects with Final Visit antrum biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days post-dosing.
Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=102 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=297 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Changes From Baseline to Final Visit in Antrum Biopsy Results
Unknown Baseline to Abnormal Final Visit
|
1 subjects
|
4 subjects
|
|
Changes From Baseline to Final Visit in Antrum Biopsy Results
Normal Baseline to Normal Final Visit
|
39 subjects
|
114 subjects
|
|
Changes From Baseline to Final Visit in Antrum Biopsy Results
Normal Baseline to Abnormal Final Visit
|
11 subjects
|
61 subjects
|
|
Changes From Baseline to Final Visit in Antrum Biopsy Results
Abnormal Baseline to Normal Final Visit
|
21 subjects
|
47 subjects
|
|
Changes From Baseline to Final Visit in Antrum Biopsy Results
Abnormal Baseline to Abnormal Final Visit
|
29 subjects
|
60 subjects
|
|
Changes From Baseline to Final Visit in Antrum Biopsy Results
Unknown Baseline to Normal Final Visit
|
1 subjects
|
11 subjects
|
PRIMARY outcome
Timeframe: Baseline and Final Visit (up to 12 months)Population: All subjects with Final Visit fundus biopsies are included. Each subject is counted only once per tissue type based on the worst diagnosis. Final Visit was the last visit of this study and no more than 14 days postdosing.
Normal=normal tissue; Unknown Baseline = Baseline biopsy not available; Abnormal diagnoses include: Reactive Gastropathy, Chronic Gastritis, Intestinal Metaplasia, Reflective Observation Mucosa-Associated Lymphoid Tissue Lymphoma, Other Abnormal.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=103 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=306 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Changes From Baseline to Final Visit in Fundus Biopsy Results
Normal Baseline to Normal Final Visit
|
55 subjects
|
198 subjects
|
|
Changes From Baseline to Final Visit in Fundus Biopsy Results
Normal Baseline to Abnormal Final Visit
|
8 subjects
|
35 subjects
|
|
Changes From Baseline to Final Visit in Fundus Biopsy Results
Abnormal Baseline to Normal Final Visit
|
17 subjects
|
33 subjects
|
|
Changes From Baseline to Final Visit in Fundus Biopsy Results
Abnormal Baseline to Abnormal Final Visit
|
21 subjects
|
35 subjects
|
|
Changes From Baseline to Final Visit in Fundus Biopsy Results
Unknown Baseline to Normal Final Visit
|
2 subjects
|
2 subjects
|
|
Changes From Baseline to Final Visit in Fundus Biopsy Results
Unknown Baseline to Abnormal Final Visit
|
0 subjects
|
3 subjects
|
SECONDARY outcome
Timeframe: Baseline and Month 1Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the Patient Assessment of Upper Gastrointestinal Disorders (PAGI) analyses.
Mean overall composite Quality of Life (QOL) score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=143 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=406 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 1 for PAGI-QOL Total Score
|
0.54 score on a scale
Standard Deviation 0.718
|
0.54 score on a scale
Standard Deviation 0.735
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=130 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=377 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 3 for PAGI-QOL Total Score
|
0.61 score on a scale
Standard Deviation 0.827
|
0.56 score on a scale
Standard Deviation 0.754
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=119 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=329 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 6 for PAGI-QOL Total Score
|
0.58 score on a scale
Standard Deviation 0.792
|
0.56 score on a scale
Standard Deviation 0.758
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=110 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=303 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 9 for PAGI-QOL Total Score
|
0.64 score on a scale
Standard Deviation 0.757
|
0.60 score on a scale
Standard Deviation 0.811
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
Mean overall composite QOL score changes were computed in response to 30 questions, each scored 0 (lowest QOL) to 5 (highest QOL). Positive changes from baseline indicate improved QOL.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=95 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=244 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for PAGI-QOL Total Score
|
0.56 score on a scale
Standard Deviation 0.725
|
0.61 score on a scale
Standard Deviation 0.809
|
SECONDARY outcome
Timeframe: Baseline and Month 1Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=143 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=394 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 1 for PAGI-SYM Total Score
|
-0.95 score on a scale
Standard Deviation 0.876
|
-0.85 score on a scale
Standard Deviation 0.874
|
SECONDARY outcome
Timeframe: Baseline and Month 3Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=130 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=364 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 3 for PAGI-SYM Total Score
|
-1.09 score on a scale
Standard Deviation 0.913
|
-0.91 score on a scale
Standard Deviation 0.896
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=119 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=318 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 6 for PAGI-SYM Total Score
|
-1.05 score on a scale
Standard Deviation 0.885
|
-0.93 score on a scale
Standard Deviation 0.856
|
SECONDARY outcome
Timeframe: Baseline and Month 9Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=109 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=292 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 9 for PAGI-SYM Total Score
|
-1.17 score on a scale
Standard Deviation 0.902
|
-0.89 score on a scale
Standard Deviation 0.903
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: All subjects who received at least 1 dose of study drug and had a value for ≥1 subscale at both baseline and after Day 1 were included in the PAGI analyses.
Mean overall composite symptom-severity score changes were computed in response to 20 questions, each scored 0 (no symptoms) to 5 (most severe symptoms). Negative changes from baseline indicate improvement in symptoms (decrease in severity).
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=95 Participants
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
n=236 Participants
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Mean Change From Baseline to Month 12 for PAGI-SYM Total Score
|
-1.08 score on a scale
Standard Deviation 0.915
|
-0.95 score on a scale
Standard Deviation 0.879
|
Adverse Events
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 90 mg QD
Serious adverse events
| Measure |
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenias
|
0.00%
0/153
|
0.23%
1/438
|
|
Ear and labyrinth disorders
Inner Ear Signs and Symptoms
|
0.00%
0/153
|
0.23%
1/438
|
|
Gastrointestinal disorders
Duodenal and Small Intestinal Stenosis and Obstruction
|
0.00%
0/153
|
0.23%
1/438
|
|
General disorders
Pain and Discomfort NEC
|
0.00%
0/153
|
0.46%
2/438
|
|
Hepatobiliary disorders
Cholecystitis and Cholelithiasis
|
0.65%
1/153
|
0.46%
2/438
|
|
Immune system disorders
Anaphylactic Responses
|
0.00%
0/153
|
0.23%
1/438
|
|
Infections and infestations
Abdominal and Gastrointestinal Infections
|
1.3%
2/153
|
0.00%
0/438
|
|
Infections and infestations
Lower Respiratory Tract and Lung Infections
|
0.65%
1/153
|
0.00%
0/438
|
|
Infections and infestations
Staphylococcal Infections
|
0.00%
0/153
|
0.23%
1/438
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
0.65%
1/153
|
0.00%
0/438
|
|
Infections and infestations
Urinary Tract Infections
|
0.00%
0/153
|
0.23%
1/438
|
|
Injury, poisoning and procedural complications
Lower Limb Fractures and Dislocations
|
0.00%
0/153
|
0.23%
1/438
|
|
Injury, poisoning and procedural complications
Non-Site Specific Injuries NEC
|
0.00%
0/153
|
0.91%
4/438
|
|
Injury, poisoning and procedural complications
Non-Site Specific Procedural Complications
|
0.00%
0/153
|
0.23%
1/438
|
|
Injury, poisoning and procedural complications
Thoracic Cage Fractures and Dislocations
|
0.00%
0/153
|
0.23%
1/438
|
|
Injury, poisoning and procedural complications
Upper Limb Fractures and Dislocations
|
0.00%
0/153
|
0.23%
1/438
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorders NEC
|
0.00%
0/153
|
0.68%
3/438
|
|
Musculoskeletal and connective tissue disorders
Joint Related Disorders NEC
|
0.00%
0/153
|
0.23%
1/438
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell Lymphomas NEC
|
0.00%
0/153
|
0.23%
1/438
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemias Acute Myeloid
|
0.65%
1/153
|
0.00%
0/438
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign Site Unspecified NEC
|
0.00%
0/153
|
0.23%
1/438
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasms Malignant
|
0.00%
0/153
|
0.23%
1/438
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Neoplasms Benign
|
0.65%
1/153
|
0.00%
0/438
|
|
Nervous system disorders
Disturbances in Consciousness NEC
|
0.65%
1/153
|
0.23%
1/438
|
|
Nervous system disorders
Migraine Headaches
|
0.65%
1/153
|
0.00%
0/438
|
|
Psychiatric disorders
Perception Disturbances
|
0.00%
0/153
|
0.23%
1/438
|
|
Renal and urinary disorders
Renal Lithiasis
|
0.00%
0/153
|
0.23%
1/438
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm and Obstruction
|
0.65%
1/153
|
0.00%
0/438
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax and Pleural Effusions NEC
|
0.00%
0/153
|
0.23%
1/438
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Thrombotic and Embolic Conditions
|
0.00%
0/153
|
0.23%
1/438
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failures (Excl Neonatal)
|
0.65%
1/153
|
0.00%
0/438
|
Other adverse events
| Measure |
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea (Excl Infective)
|
11.8%
18/153
|
7.8%
34/438
|
|
Gastrointestinal disorders
Flatulence, Bloating, and Distension
|
3.9%
6/153
|
5.9%
26/438
|
|
Gastrointestinal disorders
Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
|
6.5%
10/153
|
10.7%
47/438
|
|
Gastrointestinal disorders
Nausea and Vomiting Symptoms
|
8.5%
13/153
|
9.4%
41/438
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
14.4%
22/153
|
13.5%
59/438
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Signs and Symptoms NEC
|
7.2%
11/153
|
5.3%
23/438
|
|
Nervous system disorders
Headaches NEC
|
7.2%
11/153
|
6.2%
27/438
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER