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

Primary Purpose

Dyspepsia, Helicobacter Pylori Infection

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
RHB-105
Placebo
Sponsored by
RedHill Biopharma Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring Helicobacter pylori, H. pylori, Dyspepsia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anaheim Clinical Trials, LLC
  • Anaheim Clinical Trials
  • Catalina Research Institute
  • Jupiter Research, Inc.
  • Columbus Regional Research Institute
  • MedPharmics
  • Investigative Clinical Research
  • MGG Group Co. Chevy Chase Clinical Research
  • Detroit Clinical Research Center
  • Office of Dr. Stephen Miller, MD
  • Peters Medical Research
  • Wake Research Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RHB-105

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 4, 2013
Last Updated
September 15, 2019
Sponsor
RedHill Biopharma Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01980095
Brief Title
ERADICATE Hp - Treating Helicobacter Pylori With RHB-105
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RedHill Biopharma Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Helicobacter Pylori Infection
Keywords
Helicobacter pylori, H. pylori, Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RHB-105
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsules that look like the RHB-105 product but contain no active ingredient.
Intervention Type
Drug
Intervention Name(s)
RHB-105
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will take 4 placebo capsules every 8 hours with food for 14 days.
Primary Outcome Measure Information:
Title
The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing
Description
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.
Time Frame
28-56 days after completion of treatment
Other Pre-specified Outcome Measures:
Title
H. Pylori Eradication
Description
The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment
Time Frame
28-56 days after completion of SOC treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Y Graham, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Anaheim Clinical Trials
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Catalina Research Institute
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Jupiter Research, Inc.
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
MedPharmics
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Investigative Clinical Research
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
41401
Country
United States
Facility Name
MGG Group Co. Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Detroit Clinical Research Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Office of Dr. Stephen Miller, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34862940
Citation
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.
Results Reference
derived

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ERADICATE Hp - Treating Helicobacter Pylori With RHB-105

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