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NCT02246439 · ClinicalTrials.gov registry record · Phase 3
BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis
A Phase 3 study of Gastroenteritis and Gastritis, sponsored by RedHill Biopharma Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 330
- Enrollment target
- 20
- Study locations
NCT02246439: Completed Phase 3 study of Gastroenteritis and Gastritis, sponsored by RedHill Biopharma Limited.
NCT02246439 is a Phase 3 study of Gastroenteritis and Gastritis that has completed, run by RedHill Biopharma Limited. The registered enrollment target is 330 participants, below the 943-participant average among 3 other Gastroenteritis trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02246439, a Phase 3 study of Gastroenteritis and Gastritis, has completed, sponsored by RedHill Biopharma Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose
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 |
What the finished NCT02246439 record still lists
NCT02246439 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, below the 943-participant average among 3 other Gastroenteritis trials with a reported enrollment target (65% lower).
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.
NCT02246439 names 20 study sites across 11 states, led by New York, California, Michigan.
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.
What interventions are being tested in trial NCT02246439?
The interventions under investigation include: Placebo Oral Tablet (DRUG), RHB-102 (DRUG).
Who is sponsoring clinical trial NCT02246439?
This trial is sponsored by RedHill Biopharma Limited, which has 13 total clinical trials registered on ClinicalTrials.gov.
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.
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