Efficacy and Safety of Rifasutenizol (TNP 2198) in Participants With H. Pylori Infection

H.Pylori Infection Clinical Trial

Official title:
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Rifasutenizol (TNP 2198) in Combination With Rabeprazole and Amoxicillin in the Primary Treatment of Participants With H. Pylori Infection

Status Completed

Clinical Trial Summary

A multi-center, randomized, double-blind, bismuth-containing quadruple active comparator-controlled Phase 3 clinical study to evaluate the efficacy and safety of Rifasutenizol in combination with rabeprazole and amoxicillin in the primary treatment of participants with H. pylori infection using an adaptive design with sample size re-estimation. Subjects will be randomly assigned to test group or control group at a 1:1 ratio stratified by study site, and will receive Rifasutenizol capsules, rabeprazole sodium enteric-coated tablets, amoxicillin capsules combined with clarithromycin placebo tablets and bismuth potassium citrate placebo capsules (test group), or bismuth-containing quadruple regimen of amoxicillin capsules, clarithromycin tablets, rabeprazole sodium enteric-coated tablets and bismuth potassium citrate capsules combined with RSZ placebo capsules (control group) for 14 consecutive days. 13C UBT will be performed 4 6 weeks after the last dose to evaluate the eradication effect of H. pylori.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05857163
Study type	Interventional
Source	TenNor Therapeutics Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	May 18, 2023
Completion date	March 26, 2024

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