Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
Public ClinicalTrials.gov record NCT02757105. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Double-blind, Placebo-controlled, Phase 2 Trial of BEKINDA (Ondansetron 12 mg Bimodal Release Tablets) for Diarrhea Predominant Irritable Bowel Syndrome (IBS-D)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02757105
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 127 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 19, 2016 (Actual)
- Primary completion
- Jun 16, 2017 (Actual)
- Completion
- Jul 14, 2017 (Actual)
- Last update posted
- Aug 28, 2018
2016 – 2017
United States locations
- U.S. sites
- 16
- U.S. states
- 9
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Associates, LLC | Huntsville | Alabama | 35801 | — |
| E Squared Research, Inc. | Huntsville | Alabama | 35801 | — |
| Endoscoopy Center of AR | Little Rock | Arkansas | 72212 | — |
| Arkansas Gastroenterology, P.A. | North Little Rock | Arkansas | 72117 | — |
| Prx Clinical | Garden Grove | California | 92840 | — |
| Providence Clinical Research | North Hollywood | California | 91606 | — |
| Shahram Jacobs MD, Inc. | Sherman Oaks | California | 91403 | — |
| Advanced Rx Clinical Research Group, Inc. | Westminster | California | 92683 | — |
| Bristol Hospital Dba Connecticut Gastroenterology Institute | Bristol | Connecticut | 06010 | — |
| Clinical Research of Homestead | Homestead | Florida | 33030 | — |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | — |
| Great Lakes Medical Research | Mentor | Ohio | 44060 | — |
| Clinsearch | Chattanooga | Tennessee | 37421 | — |
| New Phase Research & Development | Knoxville | Tennessee | 37909 | — |
| Aztec Medical Research, LLC | Channelview | Texas | 77530 | — |
| Gastroenterology Research of San Antonio | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02757105, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 28, 2018 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02757105 live on ClinicalTrials.gov.