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

RedHill Biopharma

Status and phase: Completed; Phase 3

Conditions: Gastritis; Gastroenteritis

Treatments: Drug: RHB-102; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT02246439

RHB-102-01

Details and patient eligibility

About

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.

Full 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 (BEKINDA) in treating Acute Gastroenteritis, by comparing it to placebo.

Enrollment: 330 patients

Sex: All

Ages: 12 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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330 participants in 2 patient groups, including a placebo group

RHB-102

Experimental group

Description:

RHB-102, Bimodal Release Ondansetron Tablets

Treatment:

Drug: RHB-102

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo Oral Tablet