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
NCT ID: NCT04198363
Last Updated: 2023-09-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
510 participants
INTERVENTIONAL
2020-04-30
2021-11-25
Brief Summary
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Detailed Description
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The study is planned to enroll 425 patients at the beginning and will enroll a maximum of approximately 510 patients based on the interim analysis results. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
Vonoprazan 20 mg
Esomeprazole 20 mg
All participants will be asked to take one tablet in combination with bismuth containing quadruple therapy (amoxicillin, clarithromycin and bismuth potassium citrate) twice at the same time each day throughout the study.
This multi-center trial will be conducted in China. The overall time to participate in this study is 10 weeks. Participants will make multiple visits to the clinic, and 28 days after last dose of study drug for a follow-up assessment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vonoprazan 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.
Vonoprazan
Vonoprazan Tablets
Amoxicillin
Amoxicillin Capsules
Clarithromycin
Clarithromycin Tablets
Bismuth Potassium citrate
Bismuth Potassium citrate
Esomeprazole 20 mg
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.
Amoxicillin
Amoxicillin Capsules
Clarithromycin
Clarithromycin Tablets
Bismuth Potassium citrate
Bismuth Potassium citrate
Esomeprazole
Esomeprazole Tablets
Interventions
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Vonoprazan
Vonoprazan Tablets
Amoxicillin
Amoxicillin Capsules
Clarithromycin
Clarithromycin Tablets
Bismuth Potassium citrate
Bismuth Potassium citrate
Esomeprazole
Esomeprazole Tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Participants with Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion.
3. 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).
4. 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).
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Haikou people's Hosptial
Haikou, Hainan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Xiangya Hospital of Central South University, Digestive Department
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Yangzhou First People's Hospital
Yangzhou, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University Digestive Department
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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References
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Song Z, Du Q, Zhang G, Zhang Z, Liu F, Lu N, Gu L, Kuroda S, Zhou L. Vonoprazan-based quadruple therapy is non-inferior to esomeprazole-based quadruple therapy for Helicobacter pylori eradication: A multicenter, double-blind, randomized, phase 3 study. Chin Med J (Engl). 2025 Feb 18. doi: 10.1097/CM9.0000000000003437. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Vonoprazan-3002
Identifier Type: -
Identifier Source: org_study_id
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