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BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis

NCT02246439 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2019-02-20

Study results available
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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

Interventions

DRUG

RHB-102

RHB-102, Bimodal Release Ondansetron Tablets

DRUG

Placebo Oral Tablet

Placebo

Sponsors & Collaborators

  • RedHill Biopharma Limited

    lead INDUSTRY

Principal Investigators

  • Robert Silverman, MD · Long Island Jewish Hospital (LIJ)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-08
Primary Completion
2017-02-13
Completion
2017-02-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02246439 on ClinicalTrials.gov