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NCT01980095 · ClinicalTrials.gov registry record · Phase 3
ERADICATE Hp - Treating Helicobacter Pylori With RHB-105
A Phase 3 study, sponsored by RedHill Biopharma Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
NCT01980095: Completed Phase 3 study, sponsored by RedHill Biopharma Limited.
NCT01980095 is a Phase 3 study that has completed, run by RedHill Biopharma Limited. The registered enrollment target is 119 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01980095, a Phase 3 study, has completed, sponsored by RedHill Biopharma Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG RHB-105
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
What the finished NCT01980095 record still lists
NCT01980095 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01980095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01980095 about?
NCT01980095 is a clinical study titled "ERADICATE Hp - Treating Helicobacter Pylori With RHB-105". 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.
What is the current status of trial NCT01980095?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2013-11. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01980095?
The interventions under investigation include: Placebo (DRUG), RHB-105 (DRUG).
Who is sponsoring clinical trial NCT01980095?
This trial is sponsored by RedHill Biopharma Limited, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01980095's enrollment target sits among peer trials
119 1640th of 2000 higher than 360 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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