Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis
NCT02246439 · View on ClinicalTrials.gov ↗
Study Summary
Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal Release Tablets) for Acute Gastroenteritis. The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute Gastroenteritis, by comparing it to placebo.
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG RHB-102
Study Locations (20)
New York
- Kings County Hospital — Brooklyn
- University Hospital of Brooklyn — Brooklyn
- North Shore University Hospital — Manhasset
- Cohen's Children's Medical Center of NY — New Hyde Park
- Long Island Jewish Medical Center — New Hyde Park
- Staten Island University Hospital North — Staten Island
- Stony Brook University — Stony Brook
California
- Kern Medical Center — Bakersfield
- UC Davis — Sacramento
- Olive View- UCLA Medical Center — Sylmar
Michigan
- Henry Ford Health System — Detroit
- Wayne State University - Sinai Grace Hospital — Detroit
District of Columbia
- George Washington University — Washington D.C.
Florida
- University of Florida Jacksonville — Jacksonville
Maryland
- University of Maryland Medical Center — Baltimore
Massachusetts
- South Shore Hospital — South Weymouth
Minnesota
- Hennepin County Medical Center — Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2014-12-08 |
| Est. Completion | 2017-02-16 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02246439
The ClinicalTrials.gov registry entry for NCT02246439 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is RedHill Biopharma Limited, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Gastroenteritis appearing as the primary indexed condition, and to 2 interventions — of which Placebo Oral Tablet is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02246439 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New York, California, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02246439 about?
NCT02246439 is a clinical study titled "BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis". Randomized, Placebo-Controlled, Phase 3 Trial of RHB-102 (BEKINDA) (Ondansetron 24 mg Bimodal Release Tablets) for Acute Gastroenteritis. The study will evaluate the safety and efficacy of RHB-102 (BEKINDA) in treating Acute Gastroenteritis, by comparing it to placebo.
What is the current status of trial NCT02246439?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2014-12-08. Estimated completion is 2017-02-16.
What conditions does trial NCT02246439 study?
This clinical trial studies the following conditions: Gastroenteritis, Gastritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02246439?
The interventions under investigation include: Placebo Oral Tablet (DRUG), RHB-102 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02246439?
This trial is sponsored by RedHill Biopharma Limited, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02246439 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.