CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 119 enrolled
Drug / intervention
RHB-105 +1 moredrug
Likely dose
RHB-105 12.5 mgfrom 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/NCT01980095
NCT01980095Phase 3Completed
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A Randomized Placebo-Controlled Phase 3 Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter Pylori (H. Pylori) Infection in Non-investigated Dyspepsia Patients

RedHill Biopharma Limited·interventional·Posted Nov 8, 2013·Updated Sep 24, 2019

In Brief

A Phase 3 clinical trial evaluating RHB-105 and Placebo for Dyspepsia and Helicobacter Pylori Infection. Completed, enrolled 119 participants across 12 sites.

Detailed Summary

The "test and treat" strategy for treating dyspeptic patients who are H. pylori positive is rapidly becoming the standard of care. This study will test the effectiveness of RHB-105, a new triple therapy to treat H. pylori infection in dyspeptic patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyspepsia, Helicobacter Pylori Infection
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 8, 2013
Enrollment StartNov 1, 2013
Primary CompletionJun 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.7 years ago

Interventions

RHB-105drug

The intended dose is RHB-105 (12.5 mg rifabutin, 250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, equivalent to a total daily dose of: * Rifabutin 150 mg * Amoxicillin 3000 mg * Omeprazole 120 mg Subjects will take study drug every 8 hours with food for 14 consecutive days.

Placebodrug

Subjects will take 4 placebo capsules every 8 hours with food for 14 days.