Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

ERADICATE Hp - Treating Helicobacter Pylori With RHB-105 (ERADICATE Hp)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RedHill Biopharma Limited
ClinicalTrials.gov Identifier:
NCT01980095
First received: November 4, 2013
Last updated: November 13, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Dyspepsia
Helicobacter Pylori Infection
Drug: RHB-105
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by RedHill Biopharma Limited:

Primary Outcome Measures:
  • The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing [ Time Frame: 28-56 days after completion of treatment ]
    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.


Other Outcome Measures:
  • H. Pylori Eradication [ Time Frame: 28-56 days after completion of SOC treatment ]
    The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment


Enrollment: 119
Study Start Date: November 2013
Study Completion Date: August 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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 Comparator: Placebo
Capsules that look like the RHB-105 product but contain no active ingredient.
Drug: Placebo
Subjects will take 4 placebo capsules every 8 hours with food for 14 days.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01980095

Locations
United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Catalina Research Institute
Chino, California, United States, 91710
United States, Florida
Jupiter Research, Inc.
Jupiter, Florida, United States, 33458
United States, Georgia
Columbus Regional Research Institute
Columbus, Georgia, United States, 31904
United States, Louisiana
MedPharmics
Metairie, Louisiana, United States, 70006
United States, Maryland
Investigative Clinical Research
Annapolis, Maryland, United States, 41401
MGG Group Co. Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
United States, Michigan
Detroit Clinical Research Center
Farmington Hills, Michigan, United States, 48334
United States, Nevada
Office of Dr. Stephen Miller, MD
Las Vegas, Nevada, United States, 89144
United States, North Carolina
Peters Medical Research
High Point, North Carolina, United States, 27262
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Sponsors and Collaborators
RedHill Biopharma Limited
Investigators
Principal Investigator: David Y Graham, MD Baylor College of Medicine
  More Information

Responsible Party: RedHill Biopharma Limited
ClinicalTrials.gov Identifier: NCT01980095     History of Changes
Other Study ID Numbers: RHB-105-01
Study First Received: November 4, 2013
Results First Received: November 13, 2016
Last Updated: November 13, 2016

Keywords provided by RedHill Biopharma Limited:
Helicobacter pylori
H. pylori
Dyspepsia

Additional relevant MeSH terms:
Infection
Dyspepsia
Helicobacter Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 22, 2017