At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 127 enrolled
Drug / intervention
BEKINDA +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Double-blind, Placebo-controlled, Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
In Brief
A Phase 2 clinical trial evaluating BEKINDA and Placebo for Irritable Bowel Syndrome With Diarrhea. Completed, enrolled 127 participants across 16 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome With Diarrhea
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartMay 2016
Primary CompletionJun 2017
Study CompletionJul 2017
TodayJul 2026
First PostedApr 29, 2016
Enrollment StartMay 19, 2016
Primary CompletionJun 16, 2017
Study CompletionJul 14, 2017
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 10.2 years ago
Interventions
BEKINDAdrug
Placebodrug