CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
TNP-2198 +2 moredrug
Likely dose
TNP-2198 400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06076694
NCT06076694Phase 2Completed
CompareCT.gov

Single-center, Randomized, Open-label Phase Ic/IIb Clinical Study to Evaluate the Efficacy and Safety of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Combined With Multiple Doses of Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Compared With Multiple Doses of Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules Combined With Multiple Doses in Helicobacter Pylori Infection-positive Population

TenNor Therapeutics (Suzhou) Limited·interventional·Posted Oct 11, 2023·Updated Dec 12, 2023

In Brief

A Phase 2 clinical trial evaluating TNP-2198, Rabeprazole Sodium, and 1 other intervention for Helicobacter Pylori Infection. Completed, enrolled 80 participants across 1 site.

Detailed Summary

This is a single-center, randomized, open-label phase Ic/IIb clinical study to evaluate the efficacy and safety of TNP-2198 capsules, rabeprazole sodium enteric-coated tablets and amoxicillin capsules combined with multiple doses of rabeprazole sodium enteric-coated tablets and amoxicillin capsules compared with multiple doses of rabeprazole sodium enteric-coated tablets and amoxicillin capsules combined with multiple doses in Helicobacter pylori infection-positive population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHelicobacter Pylori Infection
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedOct 11, 2023
Enrollment StartJun 26, 2022
Primary CompletionSep 20, 2022
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 2.7 years ago

Interventions

TNP-2198drug

Group A, TNP-2198 capsules 400mg(4 capsules),BID, 14days Group B, TNP-2198 capsules 600mg(6 capsules),BID, 14days Group C , TNP-2198 capsules 600mg(6 capsules),TID, 14days Group D, TNP-2198 capsules 600mg(6 capsules),TID, 7days

Rabeprazole Sodiumdrug

Group A,Group B,Control group: Rabeprazole sodium enteric-coated tablets 20 mg, BID, 14days Group C :Rabeprazole sodium enteric-coated tablets 20 mg, TID, 14 days Group D : Rabeprazole sodium enteric-coated tablets 20 mg, TID, 7 days

Amoxicillindrug

Group A,Group B,Control group: Amoxicillin capsules 1g, BID, 14days Group D : Amoxicillin capsules 1g, TID, 7 days