Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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?
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, categorized as Phase 3. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 943-participant average among 3 other Gastroenteritis trials with a reported enrollment target (65% lower). The listed sponsor is RedHill Biopharma Limited, which has 13 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
Similar trials for Gastroenteritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.