ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a, randomized, double-blind, placebo-controlled study of RHB-105 in adult subjects complaining of epigastric discomfort that have been screened and found to be positive for H. pylori infection via 13C Urea Breath Test (UBT) and either fecal antigen test or CLO test. Eligible subjects will be randomized in a ratio of 1:2 between placebo arm (n=30) and the active arm (RHB-105) (n=60). Subjects will receive study drug for 14 consecutive days. Eradication of H. pylori infection will be determined based on 13C UBT conducted between 28 to 56 days after completion of study drug therapy. Subjects will be unblinded upon 13C UBT analysis. This will provide timely active therapy to all subjects enrolled in this study. Subjects in the placebo arm will be entitled to receive standard-of-care as prescribed by the treating physician following un-blinding. Eradication failures (13C UBT-positive) in the active study drug arm will undergo upper endoscopy with sampling for culture and sensitivity testing (to rifabutin, amoxicillin, clarithromycin, and metronidazole). Culture and sensitivity directed therapy as prescribed by the treating physician will be offered to these subjects.

Official Title
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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

Conditions
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Dyspepsia, Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: RHB-105
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be ≥18 years of age and ≤ 65 years Have symptoms consistent with dyspepsia of at least two weeks duration (defined as recurrent pain or discomfort centered in the upper abdomen, often with a relation to meals) Be positive for H. pylori by 13C Urea Breath Test (UBT) and also by fecal antigen test Be informed of the nature of the study and provide written informed consent before any study specific procedures are performed (or have a legally authorized representative sign consent) Exclusion Criteria: Have alarm symptoms/signs (including unexplained anemia [iron deficiency), melena / hematemesis, anorexia, dysphagia, jaundice, weight loss) Have taken antibiotics in the 4 weeks prior to screening Have taken bismuth containing medications such as peptobismol in the 4 weeks prior to screening Have a history of any previous esophageal or gastric surgery, except for simple closure of perforated ulcer Have a history of gastric outlet obstruction Have a history of hypersecretory state such as Zollinger-Ellison Syndrome Have a history of gastric cancer Have the presence of active gastric and duodenal ulcers or presence of 3 or more active ulcers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RHB-105<br>RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. | Drug: RHB-105<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Capsules that look like the RHB-105 product but contain no active ingredient. | Drug: Placebo<br>* Subjects will take 4 placebo capsules every 8 hours with food for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing | Modified intent-to-treat (mITT) population analyzed included all participants whok received at least 1 dose of study drug and underwent a 13C Urea Breath Test (UBT) at Visit 4. Participants with negative test results were to be considered treatment successes. Patients who tested positive for H. pylori infection, and those with indeterminate, not assessable, or missing results were to be considered treatment failures. The statistical hypothesis that the active treatment is superior to 70% was to be tested against the alternative hypothesis that the active treatment is statistically indistinguishable or less than 70% effective using a one-sample Z-test. | 28-56 days after completion of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, H. pylori, Dyspepsia