At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Rifasutenizol capsules, Rabeprazole sodium enteric-coated tablets, and 6 other interventions for H.Pylori Infection. Completed, enrolled 700 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
400 mg, BID, taken orally within half an hour after breakfast and dinner.
20 mg, BID, taken orally within half an hour before breakfast and dinner.
1 g, BID, taken orally within half an hour after breakfast and dinner.
BID, taken orally within half an hour after breakfast and dinner.
BID, taken orally within half an hour before breakfast and dinner.
500 mg, BID, taken orally within half an hour after breakfast and dinner.
240 mg, BID, taken orally within half an hour before breakfast and dinner.
BID, taken orally within half an hour before breakfast and dinner.