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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01980095
Recruitment Status : Completed
First Posted : November 8, 2013
Results First Posted : January 10, 2017
Last Update Posted : September 24, 2019
Information provided by (Responsible Party):
RedHill Biopharma Limited

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.

Condition or disease Intervention/treatment Phase
Dyspepsia Helicobacter Pylori Infection Drug: RHB-105 Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : November 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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:
  1. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01980095

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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
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
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Principal Investigator: David Y Graham, MD Baylor College of Medicine
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Responsible Party: RedHill Biopharma Limited Identifier: NCT01980095    
Other Study ID Numbers: RHB-105-01
First Posted: November 8, 2013    Key Record Dates
Results First Posted: January 10, 2017
Last Update Posted: September 24, 2019
Last Verified: September 2019
Keywords provided by RedHill Biopharma Limited:
Helicobacter pylori
H. pylori
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive