Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
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.
Timeline
- Start
- 2016-05-19
- Primary completion
- 2017-06-16
- Completion
- 2017-07-14
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry COUNT_OF_PARTICIPANTS RHB-102: Response: 42 Participants reads as mixed primary results NCT02757105 ↗
registry COUNT_OF_PARTICIPANTS Placebo: Response: 18 Participants reads as mixed primary results NCT02757105 ↗
registry analysis (superiority test); RHB-102 vs Placebo; p = 0.036; Chi-squared, Corrected reads as mixed primary results NCT02757105 ↗
registry COUNT_OF_PARTICIPANTS RHB-102: Response: 11 Participants reads as mixed primary results NCT02757105 ↗
registry COUNT_OF_PARTICIPANTS Placebo: Response: 5 Participants reads as mixed primary results NCT02757105 ↗
registry analysis (superiority test); RHB-102 vs Placebo; p = 0.410; Chi-squared, Corrected reads as mixed primary results NCT02757105 ↗
release “A Phase II study with BEKINDA® 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) also successfully met its primary endpoint.” reads as met primary endpoint redhillbio.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ondansetron | Other / unclassified | 12 mg | — |