Phase 3
N=321
BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis
Gastroenteritis · Gastritis
Bottom Line
View on ClinicalTrials.gov: NCT02246439 ↗Enrolled (actual)
321
Serious AEs
2.2%
Results posted
Feb 2019
Primary outcome: Primary: Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population — 126; 70; 12; 5 Participants — p=0.0406
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RHB-102 (Drug); Placebo Oral Tablet (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- RedHill Biopharma Limited
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population |
126; 70; 12; 5; 114; 65 | 0.0406 sig |
| SECONDARY Responders Through 4 Days After First Dose of Study Medication - ITT Population |
114; 67 | 0.1843 |
| SECONDARY Number of Participants Who Vomited - ITT Population |
38; 33; 131; 71; 23; 25 | 0.0166 sig |
| SECONDARY Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population |
48; 43 | 0.1049 |
| SECONDARY Number of Patients Receiving Intravenous Fluids - ITT Population |
34; 32 | 0.1235 |
| SECONDARY Severity of Nausea at Baseline - ITT Population |
2.8; 2.6; 1.1; 1.3; 0.8; 0.9 | — |
| SECONDARY Incidence and Severity of Diarrhea - ITT Population |
48; 29; 2; 2; 1; 2 | 0.5890 |
| SECONDARY Time to Discharge From Emergency Department (ED), Extended Observation Unit, or Hospital - ITT Population |
4.3; 4.3; 4.3; 4.8; 4.3; 4.2 | 0.8487 |
| SECONDARY Time to Resumption of Normal Activities (Work/School/Household) - ITT Population |
3; 3; 2; 4; 3; 3 | 0.8289 |
| SECONDARY Number of Patients Requiring Hospitalization - ITT Population |
11; 3 | 0.2005 |
| SECONDARY Number of Patients Returning to Emergency Department - ITT Population |
4; 4 | 0.5720 |
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 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 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.
Data sourced from ClinicalTrials.gov (NCT02246439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.