Clinical trial NCT01980095: ERADICATE Hp - Treating Helicobacter Pylori With RHB-105
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Helicobacter Pylori Infection
Keywords: Helicobacter pylori
H. pylori
Dyspepsia
Lead sponsor: RedHill Biopharma Limited
Sponsor class: INDUSTRY
First posted: 2013-11-08
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing
timeFrame: 28-56 days after completion of treatment
Secondary outcomes:
Other outcomes:
measure: H. Pylori Eradication
timeFrame: 28-56 days after completion of SOC treatment
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Chino
country: United States
facility: Catalina Research Institute
state: California
city: Jupiter
country: United States
facility: Jupiter Research, Inc.
state: Florida
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Metairie
country: United States
facility: MedPharmics
state: Louisiana
city: Annapolis
country: United States
facility: Investigative Clinical Research
state: Maryland
city: Chevy Chase
country: United States
facility: MGG Group Co. Chevy Chase Clinical Research
state: Maryland
city: Farmington Hills
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Las Vegas
country: United States
facility: Office of Dr. Stephen Miller, MD
state: Nevada
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
Study officials:
affiliation: Baylor College of Medicine
name: David Y Graham, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.