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NCT03198507 · ClinicalTrials.gov registry record · Phase 3
ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator
A Phase 3 study, sponsored by RedHill Biopharma Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 455
- Enrollment target
NCT03198507: Completed Phase 3 study, sponsored by RedHill Biopharma Limited.
NCT03198507 is a Phase 3 study that has completed, run by RedHill Biopharma Limited. The registered enrollment target is 455 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03198507, a Phase 3 study, has completed, sponsored by RedHill Biopharma Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 455 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 against an active comparator.
Primary Outcome
Eradication of H. pylori confirmed via 13C Urea Breath Test (UBT) testing. Subjects with negative test results (eradication of H. pylori) were considered treatment successes. Subjects who tested positive for H. pylori infection (no eradication) were considered treatment failures.
Interventions
- DRUG Active Comparator
- DRUG RHB-105
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2017-06-18 |
| Est. Completion | 2018-12-13 |
| Phase | Phase 3 |
What the finished NCT03198507 record still lists
NCT03198507 is an interventional study that assigns participants to a tested intervention. The registered 455 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 (41% lower).
The record links to 0 conditions, and to 2 interventions - of which Active Comparator is the first listed.
NCT03198507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03198507 about?
NCT03198507 is a clinical study titled "ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator". 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 against an active comparator.
What is the current status of trial NCT03198507?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 455 participants. The study started on 2017-06-18. Estimated completion is 2018-12-13.
What interventions are being tested in trial NCT03198507?
The interventions under investigation include: Active Comparator (DRUG), RHB-105 (DRUG).
Who is sponsoring clinical trial NCT03198507?
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 NCT03198507's enrollment target sits among peer trials
455 829th of 2000 higher than 1,170 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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