ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

NCT01980095 | Completed Phase 3 Results

• 1 other identifier: RHB-105-01
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 12

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.

Conditions

Dyspepsia; Helicobacter Pylori Infection

Keywords

Helicobacter pylori; H. pylori; Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• H. Pylori Eradication

  28-56 days after completion of SOC treatment

Study Arms (2)

RHB-105

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.

Drug: RHB-105

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

RHB-105 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.

RHB-105

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be ≥18 years of age and ≤ 65 years
• 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)
• Be positive for H. pylori by 13C Urea Breath Test (UBT) and also by fecal antigen test
• 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)

You may not qualify if:

• Have alarm symptoms/signs (including unexplained anemia \[iron deficiency), melena / hematemesis, anorexia, dysphagia, jaundice, weight loss)
• Have taken antibiotics in the 4 weeks prior to screening
• Have taken bismuth containing medications such as peptobismol in the 4 weeks prior to screening
• Have a history of any previous esophageal or gastric surgery, except for simple closure of perforated ulcer
• Have a history of gastric outlet obstruction
• Have a history of hypersecretory state such as Zollinger-Ellison Syndrome
• Have a history of gastric cancer
• Have the presence of active gastric and duodenal ulcers or presence of 3 or more active ulcers

Sponsors & Collaborators

• RedHill Biopharma Limited: lead

Study Sites (12)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Catalina Research Institute

Chino, California, 91710, United States

Location

Jupiter Research, Inc.

Jupiter, Florida, 33458, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

MedPharmics

Metairie, Louisiana, 70006, United States

Location

Investigative Clinical Research

Annapolis, Maryland, 41401, United States

Location

MGG Group Co. Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Detroit Clinical Research Center

Farmington Hills, Michigan, 48334, United States

Location

Office of Dr. Stephen Miller, MD

Las Vegas, Nevada, 89144, United States

Location

Peters Medical Research

High Point, North Carolina, 27262, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Related Publications (1)

• 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.

  PMID: 34862940 DERIVED

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Ira Kalfus
• Organization: RedHill Biopharma

ira@redhillbio.com

1-917-817-7517

Study Officials

• David Y Graham, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 8, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 24, 2019
• Results First Posted: January 10, 2017

Record last verified: 2019-09

Locations

US (12)