Phase 3
Completed N=119
ERADICATE Hp - Treating Helicobacter Pylori With RHB-105
Source: ClinicalTrials.gov NCT01980095 ↗Enrolled (actual)
119
Serious AEs
1.7%
Results posted
Jan 2017
Primary outcomePrimary: The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing — 59; 1; 7; 36 Participants — p=0.001
◆ Published Evidence
Emerging
11citations · ~3 / year
Pitfalls of Physician-Directed Treatment of Helicobacter pylori: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data.
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.
Linked Publications
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Pitfalls of Physician-Directed Treatment of Helicobacter pylori: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data.
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 |
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) and the linked publication. 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. Informational only — not medical advice.