BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis
Condition: Gastroenteritis; Gastritis
MeSH terms: Gastroenteritis; Gastritis; Vomiting
Intervention: RHB-102; Placebo Oral Tablet
Intervention description: RHB-102, Bimodal Release Ondansetron Tablets; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 330.0
Sex: All
Minimum age: 12 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Gastroenteritis; Gastritis; Vomiting; Nausea; Diarrhea

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.
    

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.