Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection
Duodenal Ulcer
About this trial
This is an interventional treatment trial for Duodenal Ulcer focused on measuring Drug therapy, Gastrointestinal Diseases, Digestive System Diseases, Lansoprazole, Anti-Ulcer Agents, Gastrointestinal Agents, Proton Pump Inhibitors, Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action
Eligibility Criteria
Inclusion Criteria:
1. Has endoscopic evidence of active duodenal ulcer(s) (i.e., mucosal defects with white coating [including cases associated with blood coagulation as long as there is no active bleeding]) measuring 5 mm or larger in longest diameter within 14 days prior to randomization.
Exclusion Criteria:
- Has received TAK-438 in a previous clinical study or as a therapeutic agent.
- Has a history or clinical manifestations of significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrine or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
- Has been treated with Helicobacter pylori eradication therapy within 30 days prior to study treatment.
- Has a diagnosis of duodenal malignancy or a duodenal ulcer whose morphology suggested malignancy as evident by endoscopy within 14 days prior to randomization.
- Is suspected of having acute gastro-duodenal mucosal lesions (AGDML) as evident by endoscopy within 14 days prior to randomization.
- Has a linear ulcer (including a linear ulcer scar) that has been confirmed as evident by endoscopy within 14 days prior to randomization.
- Has active postoperative (eg, endoscopic mucosal resection / endoscopic submucosal dissection) ulcer(s) as confirmed by endoscopy within 14 days prior to randomization.
- Has gastric ulcer that has been confirmed by endoscopy within 14 days prior to randomization.
- Has ulcers for which medical therapy alone is not indicated (eg, perforation, pyloric stenosis, duodenal stenosis, major bleeding).
- Has undergone therapeutic upper gastrointestinal (GI) endoscopic therapy (eg, endoscopic hemostasis or excision including biopsy) within 30 days prior to visit 1.
- Has Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion.
- Has undergone major surgical procedures within 30 days prior to Visit 1 or are scheduled to undergo surgical procedures that may affect gastric acid secretion (eg, abdominal surgery, vagotomy or craniotomy).
- Has a history of malignancy or was treated for malignancy within 5 years before the start of the visit 1 (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
- Has a known acquired immunodeficiency syndrome (AIDS) or hepatitis infection, including hepatitis virus carriers (hepatitis B surface-antigen [HBsAg] - or hepatitis C virus (HCV)-antibody-positive) (the participant may be included in the study if he/she is HCV-viral load-RNA-negative).
Laboratory tests performed prior to randomization revealed any of the following abnormalities in the participant:
- Creatinine levels: >2 mg/dL (>177 μmol/L).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST), or total bilirubin levels: > upper limit of normal (ULN).
- Has hypersensitivity to TAK-438, proton pump inhibitors (PPIs), bismuth, clarithromycin, or amoxicillin. Skin testing may be performed according to local standard practice (for HP+ participants only).
Sites / Locations
- The First Affiliated Hospital of Anhui Medical University
- Yijishan hospital of Wan nan Medical college
- Peking University First Hospital
- Beijing Chao Yang Hospital
- The General Hospital of People's Armed Police Forces China
- The Central Hospital of China Aerospace Corporation
- Beijing Friendship Hospital, Capital Medical University
- Beijing Tong Ren Hospital, Capital Medical University
- The Second Affiliated Hospital of Chongqing Medical University
- Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
- The First Affiliated Hospital of Xiamen University
- Zhangzhou Hospital
- The First People's Hospital of Foshan
- Guangdong General Hospital
- The Sixth Affiliated Hospital of Sun Yat-Sen University
- Peking University Shenzhen Hospital
- Haikou People's Hospital
- Shiyan Taihe Hospital
- Jingzhou Central Hospital
- Union Hospital of Tongji Medical College of Huazhong Science and Techology University
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
- Wuhan General Hospital of Guangzhou Military
- The 2nd Xiangya Hospital Central South University
- Chenzhou No.1 People's Hospital
- Changsha Central Hospital
- The First People's Hospital of Changzhou
- Nanjing First Hospital
- Wuxi 4th People's Hospital
- Wuxi People's Hospital
- Affiliated Hospital of Jiangsu University
- The First Affiliated Hospital of NanChang University
- Jiangxi Nanchang 3rd Hospital
- Jiangxi Pingxiang People's Hospital
- The First Hospital of Jilin University
- Jilin 4th People'S hospital
- China-Japan Union Hospital of Jilin University
- Jilin central Hospital
- Jilin Siping Central Hospital
- General Hospital of Shenyang Military Region
- General Hospital of Ningxia Medical University
- People's Hospital of Qinghai Province
- Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.
- Zhongshan Hospital Fudan University
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- Shanghai Tongji Hospital
- The 2nd Hospital of Xi An Jiaotong University
- Tianjin Medical University Affiliated General Hospital
- The First Affiliated Hospital of Kunming Medical College
- 1st Affiliated Hospital of Zhejiang University
- Zhejiang Hospital
- Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
- The Second Affiliated Hospital of Wenzhou Medical College
- The Second Affiliated Hospital Zhejiang University School of Medicine
- Yonsei University Wonju Severance Christian Hospital
- Korea University Ansan Hospital
- The Catholic University of Korea, Bucheon St. Mary s Hospital
- Hanyang Univerisy Guri Hospital
- Seoul National University Bundang Hospital
- The Catholic University of Korea, St. Vincent's Hospital
- Wonkwang University Hospital
- Chonbuk National University Hospital
- Dong-A University Hospital
- Kyungpook National University Hospital
- Yeungnam University Hospital
- Chonnam National University Hospital
- The Catholic University of Korea, Incheon St. Mary's Hospital
- Gachon University Gil Medical Center
- Korea University Anam Hospital
- Kangbuk Samsung Hospital
- Severance Hospital, Yonsei University
- Cebu Doctors University Hospital
- De La Salle University Medical Center
- Davao Doctors Hospital
- West Visayas State University Medical Center
- Philippine General Hospital
- St. Luke's Medical Center Global City
- China Medical University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Tri-Service General Hospital
- Chang Gung Memorial Hospital, Linkou
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
TAK-438 20 mg
Lansoprazole 30 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.
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.