Phase 3
N=119
ERADICATE Hp - Treating Helicobacter Pylori With RHB-105
Dyspepsia · Helicobacter Pylori Infection
Bottom Line
View on ClinicalTrials.gov: NCT01980095 ↗Enrolled (actual)
119
Serious AEs
1.7%
Results posted
Jan 2017
Primary outcome: Primary: The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing — 59; 1; 7; 36 Participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RHB-105 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- RedHill Biopharma Limited
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing |
59; 1; 7; 36 | 0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT01980095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.