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

NCT05857163 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2025-08-17

Study results available
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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.

Conditions

  • H.Pylori Infection

Interventions

DRUG

Rifasutenizol capsules

400 mg, BID, taken orally within half an hour after breakfast and dinner.

DRUG

Rabeprazole sodium enteric-coated tablets

20 mg, BID, taken orally within half an hour before breakfast and dinner.

DRUG

Amoxicillin Capsules

1 g, BID, taken orally within half an hour after breakfast and dinner.

DRUG

Clarithromycin placebo tablets

BID, taken orally within half an hour after breakfast and dinner.

DRUG

Bismuth potassium citrate placebo capsules

BID, taken orally within half an hour before breakfast and dinner.

DRUG

Clarithromycin tablets

500 mg, BID, taken orally within half an hour after breakfast and dinner.

DRUG

Bismuth potassium citrate capsules

240 mg, BID, taken orally within half an hour before breakfast and dinner.

DRUG

Rifasutenizol placebo capsules

BID, taken orally within half an hour before breakfast and dinner.

Sponsors & Collaborators

  • TenNor Therapeutics (Suzhou) Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-18
Primary Completion
2023-12-24
Completion
2024-03-26
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05857163 on ClinicalTrials.gov