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

Completed · Phase 3 · Has a placebo group

Conditions studied: Gastroenteritis, Gastritis

In brief

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.

Key facts

Study ID

NCT02246439

Run by

RedHill Biopharma Limited

People needed

330

Starts

2014-12-08

Expected to finish

2017-02-16

Last updated by the study team

2019-02-20

Who can join

Age: 12 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kern Medical Center — Bakersfield, California, United States
• UC Davis — Sacramento, California, United States
• Olive View- UCLA Medical Center — Sylmar, California, United States
• George Washington University — Washington D.C., District of Columbia, United States
• University of Florida Jacksonville — Jacksonville, Florida, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• South Shore Hospital — South Weymouth, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Wayne State University - Sinai Grace Hospital — Detroit, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Washington University - St. Louis — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Kings County Hospital — Brooklyn, New York, United States
• University Hospital of Brooklyn — Brooklyn, New York, United States
• North Shore University Hospital — Manhasset, New York, United States
• Cohen's Children's Medical Center of NY — New Hyde Park, New York, United States
• Long Island Jewish Medical Center — New Hyde Park, New York, United States
• Staten Island University Hospital North — Staten Island, New York, United States
• Stony Brook University — Stony Brook, New York, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• UPMC Mercy — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• CityDoc Urgent Care — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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