Status:
COMPLETED
BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis
Lead Sponsor:
RedHill Biopharma Limited
Conditions:
Gastroenteritis
Gastritis
Eligibility:
All Genders
12-85 years
Phase:
PHASE3
Brief 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 (B...
Detailed Description
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 (B...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 8 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2017
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT02246439
Start Date
December 8 2014
End Date
February 16 2017
Last Update
February 20 2019
Active Locations (26)
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1
Kern Medical Center
Bakersfield, California, United States, 93311
2
UC Davis
Sacramento, California, United States, 95817
3
Olive View- UCLA Medical Center
Sylmar, California, United States, 91342
4
George Washington University
Washington D.C., District of Columbia, United States, 20037