Overview

This trial is active, not recruiting.

Conditions dyspepsia, helicobacter pylori infection
Treatments rhb-105, placebo
Phase phase 3
Sponsor RedHill Biopharma Limited
Start date November 2013
End date June 2015
Trial size 120 participants
Trial identifier NCT01980095, RHB-105-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
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.
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.
(Placebo Comparator)
Capsules that look like the RHB-105 product but contain no active ingredient.
placebo
Subjects will take 4 placebo capsules every 8 hours with food for 14 days.

Primary Outcomes

Measure
The occurrence of H. pylori eradication as confirmed via 13C UBT testing
time frame: 28-56 days after completion of treatment

Secondary Outcomes

Measure
Safety - The occurrence and severity of adverse events during the study and changes from baseline in hematology and chemistry laboratory values.
time frame: 42 days
Change from Baseline in the trough concentration of amoxicillin, omeprazole, rifabutin and rifabutin metabolite 25-O-desacetyl-rifabutin on Day 8
time frame: 8 days
Change from Baseline in the trough concentration of amoxicillin, omeprazole, rifabutin and rifabutin metabolite 25-O-desacetyl-rifabutin on Day 15
time frame: 15 days

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Be ≥18 years of age and ≤ 65 years 2. 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) 3. Be positive for H. pylori by 13C Urea Breath Test (UBT) and also by fecal antigen test 4. 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: 1. Have alarm symptoms/signs (including unexplained anemia [iron deficiency), melena / hematemesis, anorexia, dysphagia, jaundice, weight loss) 2. Have taken antibiotics in the 4 weeks prior to screening 3. Have taken bismuth containing medications such as peptobismol in the 4 weeks prior to screening 4. Have a history of any previous esophageal or gastric surgery, except for simple closure of perforated ulcer 5. Have a history of gastric outlet obstruction 6. Have a history of hypersecretory state such as Zollinger-Ellison Syndrome 7. Have a history of gastric cancer 8. Have the presence of active gastric and duodenal ulcers or presence of 3 or more active ulcers

Additional Information

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
Principal investigator David Y Graham, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by RedHill Biopharma Limited.