NCT04198363

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The drug being tested in this study is called vonoprazan (TAK-438). Vonoprazan is being tested to treat people who have helicobacter pylori infection. 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

• Helicobacter Pylori

Interventions

Type	Name	Description
DRUG	Vonoprazan	Vonoprazan Tablets
DRUG	Amoxicillin	Amoxicillin Capsules
DRUG	Clarithromycin	Clarithromycin Tablets
DRUG	Bismuth Potassium citrate	Bismuth Potassium citrate
DRUG	Esomeprazole	Esomeprazole Tablets

Timeline

• Start date: 2020-04-30
• Primary completion: 2021-11-01
• Completion: 2021-11-25
• First posted: 2019-12-13
• Last updated: 2023-09-07
• Results posted: 2023-09-07

Locations

29 sites across 1 country: China