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NCT02757105 · ClinicalTrials.gov registry record · Phase 2
Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
A Phase 2 study, sponsored by RedHill Biopharma Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 127
- Enrollment target
NCT02757105: Completed Phase 2 study, sponsored by RedHill Biopharma Limited.
NCT02757105 is a Phase 2 study that has completed, run by RedHill Biopharma Limited. The registered enrollment target is 127 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02757105, a Phase 2 study, has completed, sponsored by RedHill Biopharma Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 127 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, 2-arm parallel group study. After qualifying for the study and signing informed consent, patients will undergo a two-week observation period during which stool consistency and frequency data and symptom data will be collected. Patients will then be randomized 60:40 to RHB-102 12 mg (BEKINDA) or placebo. Patients will continue on treatment for 8 weeks. Each medication will be given once daily.
Primary Outcome
A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain \>10% over baseline during that week. A patient was characterized as an overall stool consistency re
Interventions
- DRUG Placebo
- DRUG BEKINDA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2016-05-19 |
| Est. Completion | 2017-07-14 |
| Phase | Phase 2 |
What the finished NCT02757105 record still lists
NCT02757105 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02757105 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02757105 about?
NCT02757105 is a clinical study titled "Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)". This is a randomized, double-blind, placebo-controlled, 2-arm parallel group study. After qualifying for the study and signing informed consent, patients will undergo a two-week observation period during which stool consistency and frequency data and symptom data will be collected. Patients will the...
What is the current status of trial NCT02757105?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 127 participants. The study started on 2016-05-19. Estimated completion is 2017-07-14.
What interventions are being tested in trial NCT02757105?
The interventions under investigation include: Placebo (DRUG), BEKINDA (DRUG).
Who is sponsoring clinical trial NCT02757105?
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 NCT02757105's enrollment target sits among peer trials
127 555th of 2000 higher than 1,445 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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