ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

RedHill Biopharma

Status and phase: Completed; Phase 3

Conditions: Helicobacter Pylori Infection; Dyspepsia

Treatments: Drug: Placebo; Drug: RHB-105

Study type: Interventional

Funder types: Industry

Identifiers

NCT01980095

RHB-105-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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119 participants in 2 patient groups, including a placebo group

RHB-105

Experimental group

Description:

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.

Treatment:

Drug: RHB-105

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo