The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with gastric ulcer.
The drug being tested in this study is called TAK-438. TAK-438 is being tested to treat people who have stomach ulcers and also may or may not have Helicobacter pylori (HP) infection. This study will look at stomach ulcer healing and also the elimination of HP in people who take TAK-438 versus lansoprazole. The study will enroll approximately 830 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need): * TAK-438 20 mg * Lansoprazole 30 mg Study treatment will depend upon the Helicobacter pylori infection status of the participant, and include bismuth-containing quadruple therapy for the first 2 weeks in H pylori infected (HP+) participants. HP+ participants will be asked to take a TAK- 438 tablet or a lansoprazole capsule twice daily in conjunction with bismuth-containing quadruple therapy for 2 weeks, followed up by a TAK-438 tablet or a lansoprazole capsule once daily for up to 6 weeks. HP- participants will be asked to take a TAK-438 tablet or a lansoprazole capsule once daily for up to 8 weeks. This multi-center trial will be conducted in China, Korea, Taiwan, and Philippines. The overall time to participate in this study is up to 12 weeks. Participants will make multiple visits plus final visit at 2 weeks or 4 weeks after last dose of study drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
234
TAK-438 tablets
Lansoprazole capsules
TAK-438 placebo-matching tablets
Percentage of Participants With Endoscopically Confirmed Healing of Gastric Ulcers (GUs) at Weeks 4 or 8
Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically.
Time frame: Week 4 or 8
Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 8 Weeks of Treatment
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.
Time frame: 4 weeks post treatment (up to approximately 12 weeks)
Percentage of Participants With Endoscopically Confirmed Healing of GU at Week 4
Endoscopic healing was defined as the disappearance of all white coats associated with GUs confirmed endoscopically.
Time frame: Week 4
Percentage of Participants With Post-treatment Resolution of Gastrointestinal Symptoms Associated With GU
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.
Time frame: Week 2 up to Week 8
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Lansoprazole placebo-matching capsules
1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Yijishan hospital of Wan nan Medical college
Wuhu, Anhui, China
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, China
The General Hospital of People's Armed Police Forces China
Beijing, Beijing Municipality, China
The Central Hospital of China Aerospace Corporation
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tong Ren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing,P.R., Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
Fuzhou, Fujian, China
...and 71 more locations