A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection
Helicobacter Pylori
About this trial
This is an interventional treatment trial for Helicobacter Pylori focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria:
1. Helicobacter pylori (HP)-positive participants as determined by ^13C-urea breath test (^13C-UBT) at the start of the study (Visit 1 [screening]) and who require HP eradication in Physician judgment.
Exclusion Criteria:
- Participant had any of the following conditions at the start of the study (Visit 1, screening): acute upper gastrointestinal bleeding, active gastric ulcer (GU) or duodenal ulcer (DU) characterized by defective mucos with white coating (with or without adherent blood clots) 3 mm or more in size, acute gastric mucosal lesion (AGML), or acute duodenal mucosal lesion (ADML). However, participants with gastritis, gastric or duodenal erosion are permitted to participate.
- Participants with Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion.
- Participant has a history of malignancy or was treated for malignancy within 5 years before the start of the screening visit (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
- Participant has a known acquired immunodeficiency syndrome or hepatitis infection, including hepatitis virus carriers (hepatitis B surface antigen [HBsAg] or hepatitis C virus [HCV]- antibody-positive).
Sites / Locations
- Friendship Hospital, Capital Medical University
- Peking University Third Hospital
- Fuzhou General Hospital of Nanjing Military Command
- The First Affiliated Hospital of Xiamen University
- Zhongshan Hospital Xiamen University
- The First People's Hospital of Foshan
- Guangzhou First People's Hospital
- Haikou people's Hosptial
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
- Renmin Hospital of Wuhan University
- Xiangya Hospital of Central South University, Digestive Department
- The Second Xiangya Hospital of Central South University
- The Third Xiangya Hospital of Central South University
- The First People's Hospital of Changzhou
- Nanjing Drum Tower Hospital
- Jiangsu Province Hospital
- Nanjing First Hospital
- Yangzhou First People's Hospital
- Northern Jiangsu People's Hospital
- The Third Hospital of Nanchang
- The First Affiliated Hospital of Nanchang University Digestive Department
- Shengjing Hospital of China Medical University
- General Hospital of Ningxia Medical University
- Shanghai East Hospital
- Zhongshan Hospital, Fudan University
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
- The Second Affiliated Hospital of Xi'an Jiaotong University
- First Affiliated Hospital of Xinjiang Medical University
- The Second Affiliated Hospital, Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Vonoprazan 20 mg
Esomeprazole 20 mg
Vonoprazan 20 mg, tablets, orally, twice daily given in combination with bismuth containing quadruple therapy (amoxicillin 1 gm, capsules, clarithromycin 500 mg, tablets, and bismuth potassium citrate 600 mg) orally, twice daily for up to 2 weeks.
Esomeprazole 20 mg, tablets, orally, twice daily given in combination with bismuth containing quadruple therapy (amoxicillin 1 gm, capsules, clarithromycin 500 mg, tablets, and bismuth potassium citrate 600 mg) orally, twice daily for up to 2 weeks.