bekinda (ondansetron 24 mg bimodal release tablets) for vomiting due to presumed acute gastroenteritis or gastritis

Conditions: Gastroenteritis; Gastritis

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.

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.

Eligibility criteria:
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 vomiting, e.g., 5-ht3 antagonists or phenothiazines, or receipt of any iv fluid for any reason. nonspecific gastrointestinal remedies, such as antacids, proton pump inhibitors and homeopathic remedies, are permitted. * congestive heart failure, bradyarrhythmia (baseline pulse\<55/min), known long qt syndrome * patient who have known qtc prolongation \> 450 msec, noted on prior or screening ecg, or who are taking medication known to cause qt prolongation. note: for current list of medications known to cause qt prolongation see: https://www.crediblemeds.org/healthcare-providers/drug-list/ use list showing drugs with known risk tdp. * known underlying disease which could affect assessment of hydration or modify outcome of treatment, e.g., renal failure, diabetes mellitus, liver disease, alcoholism. patients with type 2 diet-controlled diabetes mellitus whose baseline blood glucose is \<200 may be entered into the study * abdominal surgery within the past 3 months * history of bariatric surgery or bowel obstruction at any time * hypersensitivity or other known intolerance to ondansetron or other 5-ht3 antagonists * patient has taken apomorphine within 24 hours of screening * patient has previously participated in this study * patient has participated in another interventional clinical trial, for any indication, in the past 30 days * for women of childbearing potential: documented or possible pregnancy.

Keywords: gastroenteritis gastritis vomiting nausea diarrhea