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

Inclusion Criteria:

• Patients must have vomited at least twice in the 4 hours preceding signing informedconsent. A vomiting episode is defined as an episode of forceful expulsion of stomachcontents. Retching if a patient has already emptied his or her gastric contents isalso considered vomiting episode. A distinct episode is characterized by a clear breakin vomiting activity of at least 5 minutes

• Emesis must have been nonbloody (streaks of blood presumed due to force of retchingare allowed)

• All patients (and a parent or guardian for patients <age 18) must sign informedconsent.

Exclusion Criteria:

• Severe dehydration. Severe dehydration is defined as two or more of the followingcriteria in the presence of decreased intake and increased output due to vomiting ordiarrhea: Absent or severely decreased urine output; weak pulse and/or low bloodpressure; parched mucous membranes; lethargy, confusion, delirium or loss ofconsciousness

• Signs and symptoms severe enough to require immediate parenteral hydration and/orparenteral antiemetic medication

• Temperature>39.0

• Likely etiologies for acute vomiting and diarrhea other than acute infectious or toxicgastroenteritis or gastritis. This includes signs of an acute abdomen, which mayrequire surgical intervention

• Chemically-induced gastroenteritis, e.g., from alcohol, other drugs of abuse or otherirritant chemicals

• Use within 24 hours of study entry of specific medication for treatment of nauseaand/or vomiting, e.g., 5-HT3 antagonists or phenothiazines, or receipt of any IV fluidfor any reason. Nonspecific gastrointestinal remedies, such as antacids, proton pumpinhibitors and homeopathic remedies, are permitted.

• Congestive heart failure, bradyarrhythmia (baseline pulse<55/min), known long QTsyndrome

• 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 ofmedications known to cause QT prolongation see:https://www.crediblemeds.org/healthcare-providers/drug-list/ Use list showing drugswith known risk TdP.

• Known underlying disease which could affect assessment of hydration or modify outcomeof 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.