ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

Phase 3

Completed

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
RHB-105	RHB-105	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.
Placebo	Placebo	Capsules that look like the RHB-105 product but contain no active ingredient.

Primary Outcome Measures

Name	Time	Method
The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing	28-56 days after completion of treatment	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.

Secondary Outcome Measures

Name	Time	Method

Locations (12): Anaheim Clinical Trials
🇺🇸
Anaheim, California, United States
Detroit Clinical Research Center
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Farmington Hills, Michigan, United States
Investigative Clinical Research
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Annapolis, Maryland, United States
Peters Medical Research
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High Point, North Carolina, United States
Wake Research Associates
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Raleigh, North Carolina, United States
MedPharmics
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Metairie, Louisiana, United States
Anaheim Clinical Trials, LLC
🇺🇸
Anaheim, California, United States
Catalina Research Institute
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Chino, California, United States
Jupiter Research, Inc.
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Jupiter, Florida, United States
Columbus Regional Research Institute
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Columbus, Georgia, United States
MGG Group Co. Chevy Chase Clinical Research
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Chevy Chase, Maryland, United States
Office of Dr. Stephen Miller, MD
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Las Vegas, Nevada, United States