ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

NCT ID: NCT01980095

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-08-31

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.

Conditions

Dyspepsia; Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

RHB-105

Intervention Type: DRUG

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

Capsules that look like the RHB-105 product but contain no active ingredient.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will take 4 placebo capsules every 8 hours with food for 14 days.

Interventions

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.

Intervention Type: DRUG

Placebo

Subjects will take 4 placebo capsules every 8 hours with food for 14 days.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RedHill Biopharma Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Y Graham, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Anaheim Clinical Trials

Anaheim, California, United States

Catalina Research Institute

Chino, California, United States

Jupiter Research, Inc.

Jupiter, Florida, United States

Columbus Regional Research Institute

Columbus, Georgia, United States

MedPharmics

Metairie, Louisiana, United States

Investigative Clinical Research

Annapolis, Maryland, United States

MGG Group Co. Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

Detroit Clinical Research Center

Farmington Hills, Michigan, United States

Office of Dr. Stephen Miller, MD

Las Vegas, Nevada, United States

Peters Medical Research

High Point, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34862940 (View on PubMed)

Other Identifiers

RHB-105-01

Identifier Type: -

Identifier Source: org_study_id