Trials / Completed
CompletedNCT02246439
BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis
Randomized, Placebo-Controlled, Phase 3 Trial of BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis (The GUARD Study)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 330 (actual)
- Sponsor
- RedHill Biopharma Limited · Industry
- Sex
- All
- Age
- 12 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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
| Type | Name | Description |
|---|---|---|
| DRUG | RHB-102 | RHB-102, Bimodal Release Ondansetron Tablets |
| DRUG | Placebo Oral Tablet | Placebo |
Timeline
- Start date
- 2014-12-08
- Primary completion
- 2017-02-13
- Completion
- 2017-02-16
- First posted
- 2014-09-22
- Last updated
- 2019-02-20
- Results posted
- 2019-02-20
Locations
26 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02246439. Inclusion in this directory is not an endorsement.