ERADICATE Hp - Treating Helicobacter Pylori With RHB-105 (ERADICATE Hp)
Helicobacter Pylori Infection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing [ Time Frame: 28-56 days after completion of treatment ] [ Designated as safety issue: No ]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.
- H. Pylori Eradication [ Time Frame: 28-56 days after completion of SOC treatment ] [ Designated as safety issue: No ]The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment
|Study Start Date:||November 2013|
|Study Completion Date:||August 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
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.
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:
Subjects will take study drug every 8 hours with food for 14 consecutive days.
Placebo Comparator: Placebo
Capsules that look like the RHB-105 product but contain no active ingredient.
Subjects will take 4 placebo capsules every 8 hours with food for 14 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01980095
|United States, California|
|Anaheim Clinical Trials, LLC|
|Anaheim, California, United States, 92801|
|Anaheim Clinical Trials|
|Anaheim, California, United States, 92801|
|Catalina Research Institute|
|Chino, California, United States, 91710|
|United States, Florida|
|Jupiter Research, Inc.|
|Jupiter, Florida, United States, 33458|
|United States, Georgia|
|Columbus Regional Research Institute|
|Columbus, Georgia, United States, 31904|
|United States, Louisiana|
|Metairie, Louisiana, United States, 70006|
|United States, Maryland|
|Investigative Clinical Research|
|Annapolis, Maryland, United States, 41401|
|MGG Group Co. Chevy Chase Clinical Research|
|Chevy Chase, Maryland, United States, 20815|
|United States, Michigan|
|Detroit Clinical Research Center|
|Farmington Hills, Michigan, United States, 48334|
|United States, Nevada|
|Office of Dr. Stephen Miller, MD|
|Las Vegas, Nevada, United States, 89144|
|United States, North Carolina|
|Peters Medical Research|
|High Point, North Carolina, United States, 27262|
|Wake Research Associates|
|Raleigh, North Carolina, United States, 27612|
|Principal Investigator:||David Y Graham, MD||Baylor College of Medicine|