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
A Randomized Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral TAK-438 20 mg Compared to Esomeprazole 20 mg Twice Daily in Subjects With Helicobacter Pylori Infection
1 other identifier
interventional
510
1 country
29
Brief Summary
The purpose of this study is to evaluate the efficacy of helicobacter pylori (HP) eradication with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all HP-positive participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2020
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
December 13, 2019
CompletedStudy Start
First participant enrolled
April 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2021
CompletedResults Posted
Study results publicly available
September 7, 2023
CompletedSeptember 7, 2023
October 1, 2022
1.5 years
December 12, 2019
October 26, 2022
October 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment
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. The percentages are rounded off to report the nearest ten.
Week 4 post-treatment
Study Arms (2)
Vonoprazan 20 mg
EXPERIMENTALVonoprazan 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
ACTIVE COMPARATOREsomeprazole 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.
Interventions
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (29)
Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, 350000, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361004, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
The First People's Hospital of Foshan
Foshan, Guangdong, 528000, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
Haikou people's Hosptial
Haikou, Hainan, 570208, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Xiangya Hospital of Central South University, Digestive Department
Changsha, Hunan, 410008, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Nanjing First Hospital
Nanjing, Jiangsu, 210029, China
Yangzhou First People's Hospital
Yangzhou, Jiangsu, 225000, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, 330000, China
The First Affiliated Hospital of Nanchang University Digestive Department
Nanchang, Jiangxi, 330006, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200000, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Related Publications (1)
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 Nov 20;138(22):2938-2946. doi: 10.1097/CM9.0000000000003437. Epub 2025 Feb 18.
PMID: 39965795DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2019
First Posted
December 13, 2019
Study Start
April 30, 2020
Primary Completion
November 1, 2021
Study Completion
November 25, 2021
Last Updated
September 7, 2023
Results First Posted
September 7, 2023
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.