- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01980095
ERADICATE Hp - Treating Helicobacter Pylori With RHB-105 (ERADICATE Hp)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
Anaheim, California, United States, 92801
- Anaheim Clinical Trials
-
Anaheim, California, United States, 92801
- Anaheim Clinical Trials, LLC
-
Chino, California, United States, 91710
- Catalina Research Institute
-
-
Florida
-
Jupiter, Florida, United States, 33458
- Jupiter Research, Inc.
-
-
Georgia
-
Columbus, Georgia, United States, 31904
- Columbus Regional Research Institute
-
-
Louisiana
-
Metairie, Louisiana, United States, 70006
- MedPharmics
-
-
Maryland
-
Annapolis, Maryland, United States, 41401
- Investigative Clinical Research
-
Chevy Chase, Maryland, United States, 20815
- MGG Group Co. Chevy Chase Clinical Research
-
-
Michigan
-
Farmington Hills, Michigan, United States, 48334
- Detroit Clinical Research Center
-
-
Nevada
-
Las Vegas, Nevada, United States, 89144
- Office of Dr. Stephen Miller, MD
-
-
North Carolina
-
High Point, North Carolina, United States, 27262
- Peters Medical Research
-
Raleigh, North Carolina, United States, 27612
- Wake Research Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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:
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.
|
Subjects will take 4 placebo capsules every 8 hours with food for 14 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
28-56 days after completion of treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
28-56 days after completion of SOC treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Y Graham, MD, Baylor College of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHB-105-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dyspepsia
-
King Chulalongkorn Memorial HospitalRecruiting
-
Wuhan Central HospitalNot yet recruiting
-
Dong-A ST Co., Ltd.Not yet recruitingFunctional DyspepsiaKorea, Republic of
-
Universitaire Ziekenhuizen KU LeuvenRecruiting
-
Universitaire Ziekenhuizen KU LeuvenRecruiting
-
Zeria PharmaceuticalRecruitingFunctional DyspepsiaJapan
-
Hong Kong Baptist UniversityXiyuan Hospital of China Academy of Chinese Medical SciencesRecruitingFunctional DyspepsiaHong Kong
-
Seoul National University HospitalCompletedFunctional DyspepsiaKorea, Republic of
-
Wonju Severance Christian HospitalCompletedFunctional DyspepsiaKorea, Republic of
-
Daewoong Pharmaceutical Co. LTD.CompletedFunctional DyspepsiaKorea, Republic of
Clinical Trials on RHB-105
-
Draeger Medical Systems, Inc.CompletedHyperbilirubinemia | Neonatal JaundiceCanada
-
Beijing InnoCare Pharma Tech Co., Ltd.Completed
-
AegisCN LLCDuke Clinical Research Institute; PharPoint Research, Inc.CompletedIntracerebral HemorrhageUnited States
-
Noema Pharma AGCompletedChildhood-Onset Fluency DisorderUnited States, Australia
-
Therapeutics, Inc.CompletedScalp PsoriasisUnited States
-
AegisCN LLCCompletedIntracerebral Hemorrhage (ICH)United States
-
Noema Pharma AGNot yet recruiting
-
InQpharm GroupTerminatedCommon Cold | Upper Respiratory Tract InfectionsGermany