BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroente… (NCT02246439) | Clinical Trial Compass
CompletedPhase 3
BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis
United States330 participantsStarted 2014-12-08
Plain-language 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.
Who can participate
Age range12 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have vomited at least twice in the 4 hours preceding signing informed consent. A vomiting episode is defined as an episode of forceful expulsion of stomach contents. Retching if a patient has already emptied his or her gastric contents is also considered vomiting episode. A distinct episode is characterized by a clear break in vomiting activity of at least 5 minutes
* Emesis must have been nonbloody (streaks of blood presumed due to force of retching are allowed)
* All patients (and a parent or guardian for patients \<age 18) must sign informed consent.
Exclusion Criteria:
* Severe dehydration. Severe dehydration is defined as two or more of the following criteria in the presence of decreased intake and increased output due to vomiting or diarrhea: Absent or severely decreased urine output; weak pulse and/or low blood pressure; parched mucous membranes; lethargy, confusion, delirium or loss of consciousness
* Signs and symptoms severe enough to require immediate parenteral hydration and/or parenteral antiemetic medication
* Temperature\>39.0
* Likely etiologies for acute vomiting and diarrhea other than acute infectious or toxic gastroenteritis or gastritis. This includes signs of an acute abdomen, which may require surgical intervention
* Chemically-induced gastroenteritis, e.g., from alcohol, other drugs of abuse or other irritant chemicals
* Use within 24 hours of study entry of specific medication for treatment of nausea and/or vomit…
What they're measuring
1
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population