At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 330 enrolled
Drug / intervention
RHB-102 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating RHB-102 and Placebo Oral Tablet for Gastroenteritis and Gastritis. Completed, enrolled 330 participants across 26 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroenteritis, Gastritis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartDec 2014
Primary CompletionFeb 2017
Study CompletionFeb 2017
TodayJul 2026
First PostedSep 22, 2014
Enrollment StartDec 8, 2014
Primary CompletionFeb 13, 2017
Study CompletionFeb 16, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.8 years ago
Interventions
RHB-102drug
RHB-102, Bimodal Release Ondansetron Tablets
Placebo Oral Tabletdrug
Placebo