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