Trial Outcomes & Findings for Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection (NCT NCT03050307)
NCT ID: NCT03050307
Last Updated: 2021-06-18
Results Overview
Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
234 participants
Primary outcome timeframe
Week 4 or 8
Results posted on
2021-06-18
Participant Flow
Participants took part in the study at 60 investigative sites in China, Korea, and Taiwan from 17 April 2017 to 26 May 2020.
Participants with a diagnosis of gastric ulcer (GU) with or without Helicobacter pylori (H. Pylori) infection were randomized in 1:1 ratio to receive TAK-438 and lansoprazole along with placebo (to keep the blind).
Participant milestones
| Measure |
TAK-438 20 mg
Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP negative (HP-) participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
|
Lansoprazole 30 mg
HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
119
|
|
Overall Study
COMPLETED
|
107
|
110
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
TAK-438 20 mg
Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP negative (HP-) participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
|
Lansoprazole 30 mg
HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Significant Protocol Deviation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Voluntary Withdrawal
|
3
|
4
|
|
Overall Study
Reason not Specified
|
1
|
1
|
Baseline Characteristics
Number analyzed is the number of participants with data available for consumption of alcohol at Baseline.
Baseline characteristics by cohort
| Measure |
TAK-438 20 mg
n=115 Participants
Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP- participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
|
Lansoprazole 30 mg
n=119 Participants
HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 13.68 • n=115 Participants
|
53.5 years
STANDARD_DEVIATION 13.37 • n=119 Participants
|
53.7 years
STANDARD_DEVIATION 13.50 • n=234 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=115 Participants
|
27 Participants
n=119 Participants
|
56 Participants
n=234 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=115 Participants
|
92 Participants
n=119 Participants
|
178 Participants
n=234 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=115 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=234 Participants
|
|
Race (NIH/OMB)
Asian
|
114 Participants
n=115 Participants
|
119 Participants
n=119 Participants
|
233 Participants
n=234 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=115 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=234 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=115 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=234 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=115 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=234 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=115 Participants
|
0 Participants
n=119 Participants
|
1 Participants
n=234 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=115 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=234 Participants
|
|
Region of Enrollment
China
|
65 Participants
n=115 Participants
|
71 Participants
n=119 Participants
|
136 Participants
n=234 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
44 Participants
n=115 Participants
|
42 Participants
n=119 Participants
|
86 Participants
n=234 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
6 Participants
n=115 Participants
|
6 Participants
n=119 Participants
|
12 Participants
n=234 Participants
|
|
Height
|
165.4 cm
STANDARD_DEVIATION 7.49 • n=115 Participants
|
167.1 cm
STANDARD_DEVIATION 7.96 • n=119 Participants
|
166.2 cm
STANDARD_DEVIATION 7.76 • n=234 Participants
|
|
Weight
|
63.76 kg
STANDARD_DEVIATION 10.743 • n=115 Participants
|
66.83 kg
STANDARD_DEVIATION 11.370 • n=119 Participants
|
65.32 kg
STANDARD_DEVIATION 11.149 • n=234 Participants
|
|
Body Mass Index
|
23.25 kg/m^2
STANDARD_DEVIATION 3.224 • n=115 Participants
|
23.85 kg/m^2
STANDARD_DEVIATION 3.255 • n=119 Participants
|
23.56 kg/m^2
STANDARD_DEVIATION 3.247 • n=234 Participants
|
|
Smoking classification
The Participant has Never Smoked
|
49 Participants
n=115 Participants
|
52 Participants
n=119 Participants
|
101 Participants
n=234 Participants
|
|
Smoking classification
The Participant is a Current Smoker
|
50 Participants
n=115 Participants
|
51 Participants
n=119 Participants
|
101 Participants
n=234 Participants
|
|
Smoking classification
The Participant is an Ex-smoker
|
16 Participants
n=115 Participants
|
16 Participants
n=119 Participants
|
32 Participants
n=234 Participants
|
|
Consumption of Alcohol
Drinks Every Day
|
9 Participants
n=115 Participants • Number analyzed is the number of participants with data available for consumption of alcohol at Baseline.
|
6 Participants
n=118 Participants • Number analyzed is the number of participants with data available for consumption of alcohol at Baseline.
|
15 Participants
n=233 Participants • Number analyzed is the number of participants with data available for consumption of alcohol at Baseline.
|
|
Consumption of Alcohol
Drinks Two Days a Week
|
20 Participants
n=115 Participants • Number analyzed is the number of participants with data available for consumption of alcohol at Baseline.
|
25 Participants
n=118 Participants • Number analyzed is the number of participants with data available for consumption of alcohol at Baseline.
|
45 Participants
n=233 Participants • Number analyzed is the number of participants with data available for consumption of alcohol at Baseline.
|
|
Consumption of Alcohol
Drinks Two Days a Month
|
17 Participants
n=115 Participants • Number analyzed is the number of participants with data available for consumption of alcohol at Baseline.
|
25 Participants
n=118 Participants • Number analyzed is the number of participants with data available for consumption of alcohol at Baseline.
|
42 Participants
n=233 Participants • Number analyzed is the number of participants with data available for consumption of alcohol at Baseline.
|
|
Consumption of Alcohol
Never Drinks
|
69 Participants
n=115 Participants • Number analyzed is the number of participants with data available for consumption of alcohol at Baseline.
|
62 Participants
n=118 Participants • Number analyzed is the number of participants with data available for consumption of alcohol at Baseline.
|
131 Participants
n=233 Participants • Number analyzed is the number of participants with data available for consumption of alcohol at Baseline.
|
|
Caffeine Consumption
Yes (>5 Times per Week)
|
22 Participants
n=115 Participants
|
29 Participants
n=119 Participants
|
51 Participants
n=234 Participants
|
|
Caffeine Consumption
No (Never or <5 Times a Week)
|
93 Participants
n=115 Participants
|
90 Participants
n=119 Participants
|
183 Participants
n=234 Participants
|
|
H pylori infection status (13C-UBT)
Positive
|
85 Participants
n=114 Participants • Number analyzed is the number of participants with data available for H. pylori Infection status at Baseline.
|
89 Participants
n=119 Participants • Number analyzed is the number of participants with data available for H. pylori Infection status at Baseline.
|
174 Participants
n=233 Participants • Number analyzed is the number of participants with data available for H. pylori Infection status at Baseline.
|
|
H pylori infection status (13C-UBT)
Negative
|
29 Participants
n=114 Participants • Number analyzed is the number of participants with data available for H. pylori Infection status at Baseline.
|
30 Participants
n=119 Participants • Number analyzed is the number of participants with data available for H. pylori Infection status at Baseline.
|
59 Participants
n=233 Participants • Number analyzed is the number of participants with data available for H. pylori Infection status at Baseline.
|
|
Characteristics of GUs: Location I
Cardiac Fundus
|
2 Participants
n=115 Participants
|
2 Participants
n=119 Participants
|
4 Participants
n=234 Participants
|
|
Characteristics of GUs: Location I
Upper Gastric Corpus
|
5 Participants
n=115 Participants
|
4 Participants
n=119 Participants
|
9 Participants
n=234 Participants
|
|
Characteristics of GUs: Location I
Middle Gastric Corpus
|
11 Participants
n=115 Participants
|
7 Participants
n=119 Participants
|
18 Participants
n=234 Participants
|
|
Characteristics of GUs: Location I
Lower Gastric Corpus
|
10 Participants
n=115 Participants
|
13 Participants
n=119 Participants
|
23 Participants
n=234 Participants
|
|
Characteristics of GUs: Location I
Gastric Angle
|
37 Participants
n=115 Participants
|
42 Participants
n=119 Participants
|
79 Participants
n=234 Participants
|
|
Characteristics of GUs: Location I
Pyloric Antral Zone
|
50 Participants
n=115 Participants
|
51 Participants
n=119 Participants
|
101 Participants
n=234 Participants
|
|
Characteristics of GUs: Location II
Anterior Wall
|
26 Participants
n=108 Participants • Number analyzed is the number of participants with data available for Characteristics of GUs: Location II at Baseline.
|
20 Participants
n=113 Participants • Number analyzed is the number of participants with data available for Characteristics of GUs: Location II at Baseline.
|
46 Participants
n=221 Participants • Number analyzed is the number of participants with data available for Characteristics of GUs: Location II at Baseline.
|
|
Characteristics of GUs: Location II
Lesser Curvature
|
50 Participants
n=108 Participants • Number analyzed is the number of participants with data available for Characteristics of GUs: Location II at Baseline.
|
63 Participants
n=113 Participants • Number analyzed is the number of participants with data available for Characteristics of GUs: Location II at Baseline.
|
113 Participants
n=221 Participants • Number analyzed is the number of participants with data available for Characteristics of GUs: Location II at Baseline.
|
|
Characteristics of GUs: Location II
Posterior Wall
|
19 Participants
n=108 Participants • Number analyzed is the number of participants with data available for Characteristics of GUs: Location II at Baseline.
|
15 Participants
n=113 Participants • Number analyzed is the number of participants with data available for Characteristics of GUs: Location II at Baseline.
|
34 Participants
n=221 Participants • Number analyzed is the number of participants with data available for Characteristics of GUs: Location II at Baseline.
|
|
Characteristics of GUs: Location II
Greater Curvature
|
13 Participants
n=108 Participants • Number analyzed is the number of participants with data available for Characteristics of GUs: Location II at Baseline.
|
15 Participants
n=113 Participants • Number analyzed is the number of participants with data available for Characteristics of GUs: Location II at Baseline.
|
28 Participants
n=221 Participants • Number analyzed is the number of participants with data available for Characteristics of GUs: Location II at Baseline.
|
|
Characteristics of GUs: Number of ulcers
|
1.3 number of ulcers
STANDARD_DEVIATION 0.56 • n=115 Participants
|
1.2 number of ulcers
STANDARD_DEVIATION 0.45 • n=119 Participants
|
1.2 number of ulcers
STANDARD_DEVIATION 0.51 • n=234 Participants
|
|
Characteristics of GUs: Ulcer morphology
Circular
|
53 Participants
n=115 Participants • Number of participants analyzed is the number of participants with data available for ulcer morphology at Baseline.
|
56 Participants
n=119 Participants • Number of participants analyzed is the number of participants with data available for ulcer morphology at Baseline.
|
109 Participants
n=234 Participants • Number of participants analyzed is the number of participants with data available for ulcer morphology at Baseline.
|
|
Characteristics of GUs: Ulcer morphology
Ellipsoid
|
47 Participants
n=115 Participants • Number of participants analyzed is the number of participants with data available for ulcer morphology at Baseline.
|
52 Participants
n=119 Participants • Number of participants analyzed is the number of participants with data available for ulcer morphology at Baseline.
|
99 Participants
n=234 Participants • Number of participants analyzed is the number of participants with data available for ulcer morphology at Baseline.
|
|
Characteristics of GUs: Ulcer morphology
Other
|
15 Participants
n=115 Participants • Number of participants analyzed is the number of participants with data available for ulcer morphology at Baseline.
|
11 Participants
n=119 Participants • Number of participants analyzed is the number of participants with data available for ulcer morphology at Baseline.
|
26 Participants
n=234 Participants • Number of participants analyzed is the number of participants with data available for ulcer morphology at Baseline.
|
|
Characteristics of GUs: Ulcer size
Miniscule (<5 mm)
|
0 Participants
n=115 Participants
|
1 Participants
n=119 Participants
|
1 Participants
n=234 Participants
|
|
Characteristics of GUs: Ulcer size
Minor (≥5 mm and <10 mm)
|
82 Participants
n=115 Participants
|
76 Participants
n=119 Participants
|
158 Participants
n=234 Participants
|
|
Characteristics of GUs: Ulcer size
Intermediate (≥10 mm and ≤20 mm)
|
33 Participants
n=115 Participants
|
42 Participants
n=119 Participants
|
75 Participants
n=234 Participants
|
|
Time since onset of current ulcers
|
4.0 days
n=115 Participants • Number analyzed is the number of participants with data available for Time since onset of current ulcers at Baseline.
|
4.0 days
n=118 Participants • Number analyzed is the number of participants with data available for Time since onset of current ulcers at Baseline.
|
4.0 days
n=233 Participants • Number analyzed is the number of participants with data available for Time since onset of current ulcers at Baseline.
|
|
Use of NSAID or LDA (except topical use) at time of onset of ulcer
Yes
|
11 Participants
n=115 Participants
|
8 Participants
n=119 Participants
|
19 Participants
n=234 Participants
|
|
Use of NSAID or LDA (except topical use) at time of onset of ulcer
No
|
104 Participants
n=115 Participants
|
111 Participants
n=119 Participants
|
215 Participants
n=234 Participants
|
|
Type of ulcers
Primary
|
96 Participants
n=115 Participants
|
103 Participants
n=119 Participants
|
199 Participants
n=234 Participants
|
|
Type of ulcers
Recurrent
|
19 Participants
n=115 Participants
|
16 Participants
n=119 Participants
|
35 Participants
n=234 Participants
|
|
Time since onset of recurrent ulcers
|
393.0 days
n=11 Participants • Number analyzed is the number of participants with data available for time since onset of recurrent ulcers at Baseline.
|
408.5 days
n=6 Participants • Number analyzed is the number of participants with data available for time since onset of recurrent ulcers at Baseline.
|
393.0 days
n=17 Participants • Number analyzed is the number of participants with data available for time since onset of recurrent ulcers at Baseline.
|
PRIMARY outcome
Timeframe: Week 4 or 8Population: Full Analysis Set (FAS) population included all randomized participants who received at least 1 dose of the study drug. Overall number of participants analyzed were participants with data available for analyses.
Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically.
Outcome measures
| Measure |
TAK-438 20 mg
n=112 Participants
Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP- participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
|
Lansoprazole 30 mg
n=114 Participants
HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
|
|---|---|---|
|
Percentage of Participants With Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 8
|
91.1 percentage of participants
Interval 84.193 to 95.635
|
94.7 percentage of participants
Interval 88.896 to 98.044
|
SECONDARY outcome
Timeframe: 4 weeks post treatment (up to approximately 12 weeks)Population: FAS population included all randomized participants who received at least 1 dose of the study drug. Overall number of participants analyzed were participants with data available for analyses.
HP infection status was determined by 13C-UBT. The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. The data is provided only for HP+ participants. The participant could take 4 or 8 weeks of treatment for GU healing, then additional 4 weeks later, to have the urea breath test (UBT) test to detect HP.
Outcome measures
| Measure |
TAK-438 20 mg
n=75 Participants
Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP- participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
|
Lansoprazole 30 mg
n=73 Participants
HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
|
|---|---|---|
|
Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment
|
88.0 percentage of participants
Interval 78.439 to 94.363
|
80.8 percentage of participants
Interval 69.921 to 89.099
|
SECONDARY outcome
Timeframe: Week 4Population: FAS population included all randomized participants who received at least 1 dose of the study drug. Overall number of participants analyzed were participants with data available for analyses.
Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically.
Outcome measures
| Measure |
TAK-438 20 mg
n=109 Participants
Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP- participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
|
Lansoprazole 30 mg
n=112 Participants
HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
|
|---|---|---|
|
Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 4
|
76.1 percentage of participants
Interval 67.035 to 83.788
|
82.1 percentage of participants
Interval 73.777 to 88.738
|
SECONDARY outcome
Timeframe: Week 2 up to Week 8Population: FAS population included all randomized participants who received at least 1 dose of the study drug. Number analyzed is the number of participants with data available for analysis for the specific category.
The gastrointestinal symptoms included epigastric pain \[postprandial, fasting, nocturnal\], abdominal bloating, nausea/vomiting, heartburn, lack of appetite. The severity of gastrointestinal symptoms associated with GU were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3. The data is reported in categories for percentage of participants with resolution of gastrointestinal symptoms associated with GU.
Outcome measures
| Measure |
TAK-438 20 mg
n=115 Participants
Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP- participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
|
Lansoprazole 30 mg
n=119 Participants
HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
|
|---|---|---|
|
Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU
Epigastric Pain (Postprandial)
|
78.9 percentage of participants
Interval 54.435 to 93.948
|
80.0 percentage of participants
Interval 59.296 to 93.169
|
|
Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU
Epigastric Pain (Fasting/Nocturnal)
|
85.0 percentage of participants
Interval 70.165 to 94.29
|
80.5 percentage of participants
Interval 65.133 to 91.179
|
|
Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU
Abdominal Bloating
|
81.3 percentage of participants
Interval 54.354 to 95.953
|
65.2 percentage of participants
Interval 42.734 to 83.624
|
|
Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU
Nausea/Vomiting
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
100.0 percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU
Heartburn
|
95.8 percentage of participants
Interval 78.88 to 99.895
|
85.7 percentage of participants
Interval 67.335 to 95.966
|
|
Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU
Lack of Appetite
|
77.8 percentage of participants
Interval 39.991 to 97.186
|
90.0 percentage of participants
Interval 55.498 to 99.747
|
Adverse Events
TAK-438 20 mg
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Lansoprazole 30 mg
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAK-438 20 mg
n=115 participants at risk
Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP- participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
|
Lansoprazole 30 mg
n=119 participants at risk
HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/115 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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.
|
0.84%
1/119 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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
Appendicitis
|
0.87%
1/115 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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%
0/119 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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
Liver abscess
|
0.00%
0/115 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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.
|
0.84%
1/119 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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
Meningitis
|
0.87%
1/115 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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%
0/119 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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
|
0.87%
1/115 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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%
0/119 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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 |
TAK-438 20 mg
n=115 participants at risk
Helicobacter Pylori positive (HP+) participants: TAK-438 20 mg tablet, twice daily (BID) along with lansoprazole placebo-matching, capsule BID in addition to bismuth-containing quadruple antibiotic therapy for the first 2 weeks. Following 2 weeks of eradication therapy participants received TAK-438 20 mg QD along with lansoprazole matching placebo 30 mg, capsule QD for up to 6 weeks. HP- participants: TAK-438 20 mg tablet, (QD) along with lansoprazole matching placebo, 30 mg capsule QD for up to 8 weeks.
|
Lansoprazole 30 mg
n=119 participants at risk
HP+ participants: Lansoprazole 30 mg, capsule, orally, BID and TAK-438 placebo-matching tablet, orally, BID along with bismuth-containing quadruple antibiotic therapy for first 2 weeks. Following 2 weeks participants received Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 6 weeks. HP- participants: Lansoprazole 30 mg, capsule, orally, QD along with TAK-438 placebo-matching tablet, orally, QD for up to 8 weeks.
|
|---|---|---|
|
Investigations
Pepsinogen test positive
|
25.2%
29/115 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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.
|
5.0%
6/119 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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.
|
|
Investigations
Pepsinogen I increased
|
20.0%
23/115 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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.
|
6.7%
8/119 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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.
|
|
Investigations
Blood gastrin increased
|
20.9%
24/115 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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.
|
4.2%
5/119 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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.
|
|
Investigations
Alanine aminotransferase increased
|
5.2%
6/115 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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.
|
2.5%
3/119 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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
Dysgeusia
|
1.7%
2/115 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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.
|
5.9%
7/119 • From first dose up to 4 weeks post dose (up to approximately 12 weeks)
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
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER