ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

NCT01980095 ↗

Phase 3 Completed 119 enrolled RedHill Biopharma Limited

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2013-11
Primary completion: 2015-06
Completion: 2015-08

Outcome

Met primary endpoint

registry analysis (unspecified test); RHB-105; p = 0.001; One-sample Z-test, RHB-105 subjects only NCT01980095 ↗

release “The first Phase III study with TALICIA® (ERADICATE Hp study) successfully met its primary endpoint” redhillbio.com ↗

Publications

Howden CW, Sheldon KL, Almenoff JS, Chey WD. Pitfalls of Physician-Directed Treatment of Helicobacter pylori: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data. Dig Dis Sci. 2022 Sep;67(9):4382-4386. doi: 10.1007/s10620-021-07323-5. Epub 2021 Dec 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amoxicillin	Other / unclassified	250 mg	Oral
Subject	Omeprazole	Other / unclassified	10 mg	Oral
Subject	Rifabutin	Small molecule	12.5 mg	Oral