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

• Status: Completed
• Trial end date: 2017-02-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RedHill Biopharma Limited
• Treatments: Ondansetron

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 patientsconsent.

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.