ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

Helicobacter Pylori Infection Clinical Trial

— ERADICATE Hp  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980095
• Other study ID #: RHB-105-01
• Status: Completed
• Phase: Phase 3
• Start date: November 2013
• Est. completion date: August 2015

Study information

• Verified date: September 2019
• Source: RedHill Biopharma Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Helicobacter Pylori Infection
• Infection

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
RedHill Biopharma Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	H. Pylori Eradication	The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment	28-56 days after completion of SOC treatment
Primary	The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing	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.	28-56 days after completion of treatment