Trial Outcomes & Findings for Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection (NCT NCT03050359)
NCT ID: NCT03050359
Last Updated: 2020-06-12
Results Overview
Endoscopic healing was defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
533 participants
Primary outcome timeframe
Week 4 or Week 6
Results posted on
2020-06-12
Participant Flow
Participants took part in the study at 52 investigative sites in China, Korea, and Taiwan from 05 April 2017 to 19 July 2019.
Participants with or without diagnosis of Helicobacter pylori (H. Pylori) Infection were enrolled and randomly assigned in 1:1 ratio to receive either TAK-438 20 mg or lansoprazole 30 mg along with matching placebo (to keep the blind).
Participant milestones
| Measure |
TAK-438 20 mg
H. pylori negative (HP -) participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. H. pylori positive (HP +) participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
|
Lansoprazole 30 mg
H. pylori negative (HP -) participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
265
|
268
|
|
Overall Study
COMPLETED
|
248
|
248
|
|
Overall Study
NOT COMPLETED
|
17
|
20
|
Reasons for withdrawal
| Measure |
TAK-438 20 mg
H. pylori negative (HP -) participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. H. pylori positive (HP +) participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
|
Lansoprazole 30 mg
H. pylori negative (HP -) participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
|
|---|---|---|
|
Overall Study
Randomized But Not Treated
|
2
|
0
|
|
Overall Study
Pretreatment Event/Adverse Event
|
5
|
10
|
|
Overall Study
Significant Protocol Deviation
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Voluntary Withdrawal
|
4
|
6
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Reason Not Specified
|
1
|
0
|
Baseline Characteristics
Number analyzed is the number of participants with data available for weight at Baseline.
Baseline characteristics by cohort
| Measure |
TAK-438 20 mg
n=265 Participants
HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
|
Lansoprazole 30 mg
n=268 Participants
HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
|
Total
n=533 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.0 years
STANDARD_DEVIATION 12.18 • n=265 Participants
|
41.4 years
STANDARD_DEVIATION 12.89 • n=268 Participants
|
41.7 years
STANDARD_DEVIATION 12.53 • n=533 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=265 Participants
|
92 Participants
n=268 Participants
|
191 Participants
n=533 Participants
|
|
Sex: Female, Male
Male
|
166 Participants
n=265 Participants
|
176 Participants
n=268 Participants
|
342 Participants
n=533 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=265 Participants
|
0 Participants
n=268 Participants
|
0 Participants
n=533 Participants
|
|
Race (NIH/OMB)
Asian
|
265 Participants
n=265 Participants
|
268 Participants
n=268 Participants
|
533 Participants
n=533 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=265 Participants
|
0 Participants
n=268 Participants
|
0 Participants
n=533 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=265 Participants
|
0 Participants
n=268 Participants
|
0 Participants
n=533 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=265 Participants
|
0 Participants
n=268 Participants
|
0 Participants
n=533 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=265 Participants
|
0 Participants
n=268 Participants
|
0 Participants
n=533 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=265 Participants
|
0 Participants
n=268 Participants
|
0 Participants
n=533 Participants
|
|
Region of Enrollment
China
|
252 Participants
n=265 Participants
|
255 Participants
n=268 Participants
|
507 Participants
n=533 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
10 Participants
n=265 Participants
|
8 Participants
n=268 Participants
|
18 Participants
n=533 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
3 Participants
n=265 Participants
|
5 Participants
n=268 Participants
|
8 Participants
n=533 Participants
|
|
Height
|
166.1 centimeter (cm)
STANDARD_DEVIATION 8.21 • n=265 Participants
|
167.1 centimeter (cm)
STANDARD_DEVIATION 8.09 • n=268 Participants
|
166.6 centimeter (cm)
STANDARD_DEVIATION 8.16 • n=533 Participants
|
|
Weight
|
63.45 kilograms (kg)
STANDARD_DEVIATION 12.342 • n=263 Participants • Number analyzed is the number of participants with data available for weight at Baseline.
|
64.00 kilograms (kg)
STANDARD_DEVIATION 11.383 • n=268 Participants • Number analyzed is the number of participants with data available for weight at Baseline.
|
63.72 kilograms (kg)
STANDARD_DEVIATION 11.860 • n=531 Participants • Number analyzed is the number of participants with data available for weight at Baseline.
|
|
Body Mass Index (BMI)
|
22.87 kg/m^2
STANDARD_DEVIATION 3.365 • n=263 Participants • Number analyzed is the number of participants with data available for BMI at Baseline.
|
22.83 kg/m^2
STANDARD_DEVIATION 3.181 • n=268 Participants • Number analyzed is the number of participants with data available for BMI at Baseline.
|
22.85 kg/m^2
STANDARD_DEVIATION 3.270 • n=531 Participants • Number analyzed is the number of participants with data available for BMI at Baseline.
|
|
Smoking Classification
The Participant Has Never Smoked
|
164 Participants
n=265 Participants
|
165 Participants
n=268 Participants
|
329 Participants
n=533 Participants
|
|
Smoking Classification
The Participant Is a Current Smoker
|
86 Participants
n=265 Participants
|
84 Participants
n=268 Participants
|
170 Participants
n=533 Participants
|
|
Smoking Classification
The Participant Is an Ex-smoker
|
15 Participants
n=265 Participants
|
19 Participants
n=268 Participants
|
34 Participants
n=533 Participants
|
|
Consumption of Alcohol
Drink Everyday
|
6 Participants
n=265 Participants
|
2 Participants
n=268 Participants
|
8 Participants
n=533 Participants
|
|
Consumption of Alcohol
Drink a Couple of Days Per Week
|
20 Participants
n=265 Participants
|
21 Participants
n=268 Participants
|
41 Participants
n=533 Participants
|
|
Consumption of Alcohol
Drink a Couple of Days Per Month
|
48 Participants
n=265 Participants
|
58 Participants
n=268 Participants
|
106 Participants
n=533 Participants
|
|
Consumption of Alcohol
Never Drink
|
191 Participants
n=265 Participants
|
187 Participants
n=268 Participants
|
378 Participants
n=533 Participants
|
|
Consumption of Caffeine
Yes (More Than 5 Times Per Week)
|
23 Participants
n=265 Participants
|
16 Participants
n=268 Participants
|
39 Participants
n=533 Participants
|
|
Consumption of Caffeine
No (Never Drink or Less Than 5 Times Per Week)
|
242 Participants
n=265 Participants
|
252 Participants
n=268 Participants
|
494 Participants
n=533 Participants
|
|
History of H.pylori Eradication Therapy
Yes (Therapy Received Ever)
|
16 Participants
n=265 Participants
|
5 Participants
n=268 Participants
|
21 Participants
n=533 Participants
|
|
History of H.pylori Eradication Therapy
No (Never Receive Any Therapy)
|
249 Participants
n=265 Participants
|
263 Participants
n=268 Participants
|
512 Participants
n=533 Participants
|
|
H. pylori Infection Status
Positive
|
226 Participants
n=263 Participants • Number analyzed is the number of participants with data available for H. pylori Infection status at Baseline.
|
229 Participants
n=267 Participants • Number analyzed is the number of participants with data available for H. pylori Infection status at Baseline.
|
455 Participants
n=530 Participants • Number analyzed is the number of participants with data available for H. pylori Infection status at Baseline.
|
|
H. pylori Infection Status
Negative
|
37 Participants
n=263 Participants • Number analyzed is the number of participants with data available for H. pylori Infection status at Baseline.
|
38 Participants
n=267 Participants • Number analyzed is the number of participants with data available for H. pylori Infection status at Baseline.
|
75 Participants
n=530 Participants • Number analyzed is the number of participants with data available for H. pylori Infection status at Baseline.
|
|
Characteristics of Current Duodenal Ulcers (DU): Location
Superior Part (Including Bulb)
|
262 Participants
n=265 Participants • Number analyzed is the number of participants with data available for location of ulcer at Baseline.
|
266 Participants
n=267 Participants • Number analyzed is the number of participants with data available for location of ulcer at Baseline.
|
528 Participants
n=532 Participants • Number analyzed is the number of participants with data available for location of ulcer at Baseline.
|
|
Characteristics of Current Duodenal Ulcers (DU): Location
Descending Part
|
3 Participants
n=265 Participants • Number analyzed is the number of participants with data available for location of ulcer at Baseline.
|
1 Participants
n=267 Participants • Number analyzed is the number of participants with data available for location of ulcer at Baseline.
|
4 Participants
n=532 Participants • Number analyzed is the number of participants with data available for location of ulcer at Baseline.
|
|
Characteristics of Current DU: Mean Number of Ulcers Found
|
1.2 number of ulcers
STANDARD_DEVIATION 0.48 • n=263 Participants • Number analyzed is the number of participants with data available for number of ulcers found at Baseline.
|
1.3 number of ulcers
STANDARD_DEVIATION 0.54 • n=268 Participants • Number analyzed is the number of participants with data available for number of ulcers found at Baseline.
|
1.2 number of ulcers
STANDARD_DEVIATION 0.51 • n=531 Participants • Number analyzed is the number of participants with data available for number of ulcers found at Baseline.
|
|
Characteristics of Current DU: Ulcer Morphology
Circular
|
110 Participants
n=265 Participants
|
117 Participants
n=268 Participants
|
227 Participants
n=533 Participants
|
|
Characteristics of Current DU: Ulcer Morphology
Ellipsoidal
|
109 Participants
n=265 Participants
|
107 Participants
n=268 Participants
|
216 Participants
n=533 Participants
|
|
Characteristics of Current DU: Ulcer Morphology
Other
|
46 Participants
n=265 Participants
|
44 Participants
n=268 Participants
|
90 Participants
n=533 Participants
|
|
Characteristics of Current DU: Ulcer Size
Minuscule (<5 mm)
|
0 Participants
n=265 Participants
|
1 Participants
n=268 Participants
|
1 Participants
n=533 Participants
|
|
Characteristics of Current DU: Ulcer Size
Minor (>=5 mm/<10 mm)
|
183 Participants
n=265 Participants
|
188 Participants
n=268 Participants
|
371 Participants
n=533 Participants
|
|
Characteristics of Current DU: Ulcer Size
Intermediate (>=10 mm/<=20 mm)
|
81 Participants
n=265 Participants
|
78 Participants
n=268 Participants
|
159 Participants
n=533 Participants
|
|
Characteristics of Current DU: Ulcer Size
Large (>20 mm/<30 mm)
|
1 Participants
n=265 Participants
|
0 Participants
n=268 Participants
|
1 Participants
n=533 Participants
|
|
Characteristics of Current DU: Ulcer Size
Giant (>=30 mm)
|
0 Participants
n=265 Participants
|
1 Participants
n=268 Participants
|
1 Participants
n=533 Participants
|
|
History of DU: Time Since Onset of Current Ulcers
|
1.0 days
n=265 Participants
|
1.0 days
n=268 Participants
|
1.0 days
n=533 Participants
|
|
Use of NSAIDs or Low-dose Aspirin at the Time of Ulcer Onset
Yes
|
1 Participants
n=265 Participants
|
2 Participants
n=268 Participants
|
3 Participants
n=533 Participants
|
|
Use of NSAIDs or Low-dose Aspirin at the Time of Ulcer Onset
No
|
264 Participants
n=265 Participants
|
266 Participants
n=268 Participants
|
530 Participants
n=533 Participants
|
|
History of DU: Type of Ulcers
Primary
|
230 Participants
n=265 Participants
|
227 Participants
n=268 Participants
|
457 Participants
n=533 Participants
|
|
History of DU: Type of Ulcers
Recurrent
|
35 Participants
n=265 Participants
|
41 Participants
n=268 Participants
|
76 Participants
n=533 Participants
|
|
Time Since Onset of Recurrent Ulcers
|
1149.3 days
STANDARD_DEVIATION 910.72 • n=265 Participants
|
999.7 days
STANDARD_DEVIATION 828.57 • n=268 Participants
|
1068.7 days
STANDARD_DEVIATION 859.12 • n=533 Participants
|
PRIMARY outcome
Timeframe: Week 4 or Week 6Population: Full Analysis Set (FAS) included all participants who were randomized and 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 duodenal ulcers as confirmed endoscopically.
Outcome measures
| Measure |
Lansoprazole 30 mg
n=255 Participants
HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
|
TAK-438 20 mg
n=254 Participants
HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
|
|---|---|---|
|
Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcers
|
96.5 percentage of participants
Interval 93.406 to 98.374
|
96.9 percentage of participants
Interval 93.889 to 98.631
|
SECONDARY outcome
Timeframe: 4 weeks post treatment (Up to 10 weeks)Population: Participants from FAS, included all participants who were randomized and received at least 1 dose of the study drug with H pylori positive status at Baseline with data available for analyses.
HP infection status was determined by \^13C Urea Breath Test (\^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.
Outcome measures
| Measure |
Lansoprazole 30 mg
n=204 Participants
HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
|
TAK-438 20 mg
n=211 Participants
HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
|
|---|---|---|
|
Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 6 Weeks of Treatment
|
86.8 percentage of participants
Interval 81.33 to 91.093
|
91.5 percentage of participants
Interval 86.853 to 94.866
|
SECONDARY outcome
Timeframe: Week 4Population: FAS included all participants who were randomized and received at least 1 dose of the study drug. Overall number of participants analyzed were participants with data available for analyses.
Endoscopic healing is defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically.
Outcome measures
| Measure |
Lansoprazole 30 mg
n=251 Participants
HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
|
TAK-438 20 mg
n=249 Participants
HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
|
|---|---|---|
|
Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4
|
88.4 percentage of participants
Interval 83.83 to 92.124
|
89.2 percentage of participants
Interval 84.617 to 92.731
|
SECONDARY outcome
Timeframe: Week 2 up to Week 6Population: FAS included all participants who were randomized and received at least 1 dose of the study drug. Number analyzed is number of participants analyzed for the particular category (symptom).
The percentage of participants with resolution of various gastrointestinal symptoms are reported as categories. Gastrointestinal symptoms included epigastric pain (postprandial, fasting, nocturnal), abdominal bloating, nausea/vomiting, heartburn and lack of appetite. The severity of subjective symptoms of erosive esophagitis were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3.
Outcome measures
| Measure |
Lansoprazole 30 mg
n=268 Participants
HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
|
TAK-438 20 mg
n=263 Participants
HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
|
|---|---|---|
|
Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6
Lack of Appetite
|
100.0 percentage of participants
Interval 81.47 to 100.0
|
90.9 percentage of participants
Interval 70.839 to 98.879
|
|
Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6
Epigastric Pain (Postprandial)
|
91.8 percentage of participants
Interval 80.399 to 97.731
|
87.7 percentage of participants
Interval 76.321 to 94.917
|
|
Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6
Epigastric Pain (Fasting/Nocturnal)
|
90.1 percentage of participants
Interval 83.902 to 94.465
|
91.7 percentage of participants
Interval 85.579 to 95.767
|
|
Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6
Abdominal Bloating
|
87.3 percentage of participants
Interval 76.503 to 94.355
|
83.3 percentage of participants
Interval 69.778 to 92.519
|
|
Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6
Nausea/Vomiting
|
94.4 percentage of participants
Interval 72.706 to 99.859
|
85.2 percentage of participants
Interval 66.269 to 95.811
|
|
Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6
Heartburn
|
95.5 percentage of participants
Interval 77.156 to 99.885
|
100.0 percentage of participants
Interval 87.656 to 100.0
|
Adverse Events
TAK-438 20 mg
Serious events: 1 serious events
Other events: 162 other events
Deaths: 0 deaths
Lansoprazole 30 mg
Serious events: 3 serious events
Other events: 113 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAK-438 20 mg
n=263 participants at risk
HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
|
Lansoprazole 30 mg
n=268 participants at risk
HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.38%
1/263 • Up to Week 10 (Up to 6 weeks of treatment)
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%
0/268 • Up to Week 10 (Up to 6 weeks of treatment)
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
|
0.00%
0/263 • Up to Week 10 (Up to 6 weeks of treatment)
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.
|
0.37%
1/268 • Up to Week 10 (Up to 6 weeks of treatment)
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)
Bladder transitional cell carcinoma
|
0.00%
0/263 • Up to Week 10 (Up to 6 weeks of treatment)
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.
|
0.37%
1/268 • Up to Week 10 (Up to 6 weeks of treatment)
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.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/263 • Up to Week 10 (Up to 6 weeks of treatment)
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.
|
0.37%
1/268 • Up to Week 10 (Up to 6 weeks of treatment)
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=263 participants at risk
HP - participants: TAK-438 20 mg, tablets, orally, once daily (QD) and lansoprazole placebo-matching capsules, orally, QD for up to 6 weeks. HP + participants: TAK-438 20 mg, tablets, orally, twice daily (BID) and lansoprazole placebo-matching capsules, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed byTAK-438 20 mg, tablets, orally, QD and lansoprazole placebo-matching capsules, orally, QD for up to 4 weeks.
|
Lansoprazole 30 mg
n=268 participants at risk
HP - participants: lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, QD for up to 6 weeks. HP + participants: lansoprazole 30 mg, capsules, orally, BID and TAK-438 placebo-matching tablets, orally, BID for first 2 weeks along with Bismuth-Containing Quadruple Therapy followed by lansoprazole 30 mg, capsules, orally, QD and TAK-438 placebo-matching tablets, orally, BID for up to 4 weeks.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
8.0%
21/263 • Up to Week 10 (Up to 6 weeks of treatment)
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.
|
13.8%
37/268 • Up to Week 10 (Up to 6 weeks of treatment)
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 test positive
|
47.1%
124/263 • Up to Week 10 (Up to 6 weeks of treatment)
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.
|
10.4%
28/268 • Up to Week 10 (Up to 6 weeks of treatment)
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
|
35.0%
92/263 • Up to Week 10 (Up to 6 weeks of treatment)
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.
|
13.8%
37/268 • Up to Week 10 (Up to 6 weeks of treatment)
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
|
36.9%
97/263 • Up to Week 10 (Up to 6 weeks of treatment)
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.
|
7.5%
20/268 • Up to Week 10 (Up to 6 weeks of treatment)
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
Protein urine present
|
7.6%
20/263 • Up to Week 10 (Up to 6 weeks of treatment)
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.
|
4.1%
11/268 • Up to Week 10 (Up to 6 weeks of treatment)
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
|
4.6%
12/263 • Up to Week 10 (Up to 6 weeks of treatment)
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.
|
6.3%
17/268 • Up to Week 10 (Up to 6 weeks of treatment)
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
|
8.0%
21/263 • Up to Week 10 (Up to 6 weeks of treatment)
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.
|
8.2%
22/268 • Up to Week 10 (Up to 6 weeks of treatment)
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