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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 is a Phase 2 study that has completed, run by RedHill Biopharma Limited. The registered enrollment target is 127 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02757105
The ClinicalTrials.gov registry entry for NCT02757105 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RedHill Biopharma Limited, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02757105 reports 0 study locations.
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.
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