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ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

NCT01980095 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2019-09-24

Study results available
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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.

Conditions

  • Dyspepsia
  • Helicobacter Pylori Infection

Interventions

DRUG

RHB-105

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • RedHill Biopharma Limited

    lead INDUSTRY

Principal Investigators

  • David Y Graham, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-06-30
Completion
2015-08-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT01980095 on ClinicalTrials.gov