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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
330
RHB-102, Bimodal Release Ondansetron Tablets
Placebo
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population
Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose
Time frame: 24 Hours
Responders Through 4 Days After First Dose of Study Medication - ITT Population
Treatment success, as defined in the primary outcome, through 4 days following first dose of study medication.
Time frame: 4 Days
Number of Participants Who Vomited - ITT Population
Analysis of vomiting from 30 minutes after first administration of study medication until 24 hours post first dose
Time frame: 24 Hours
Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population
Patients receiving rescue antiemetic therapy within 24 hours after the first dose of study medication.
Time frame: 24 Hours
Number of Patients Receiving Intravenous Fluids - ITT Population
Patients receiving parenteral hydration within 24 hours after the first dose of study medication.
Time frame: 24 Hours
Severity of Nausea at Baseline - ITT Population
Severity of nausea was assessed using a 5-point Likert scale: 0=no nausea; 1=mild nausea; 2=moderate nausea; 3=severe nausea; 4=nausea as bad as can be.
Time frame: Day 1 - Baseline through 5 Hours Post Dose
Incidence and Severity of Diarrhea - ITT Population
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 16 more locations
Severity of diarrhea for patients having bowel movements was assessed using the Bristol Stool Scale ("BSS"), a Likert scale rating bowel movements from 1=separate hard lumps, like nuts, to 7=watery, no solid pieces; entirely liquid. The BSS was added to the emergency room day and follow-up diaries beginning with protocol amendment 3.
Time frame: From 30 Minutes Through 24 Hours after First Dose of Study Medication
Time to Discharge From Emergency Department (ED), Extended Observation Unit, or Hospital - ITT Population
Time from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last, and when clinically appropriate.
Time frame: Hours from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last
Time to Resumption of Normal Activities (Work/School/Household) - ITT Population
Time from first dose of study medication to resumption of normal activities (work/school/household).
Time frame: Hours from first dose of study medication to resumption of normal activities
Number of Patients Requiring Hospitalization - ITT Population
Number of patients requiring hospitalization. 4 patients in the RHB-102 treatment group and 1 patient in the placebo treatment group were hospitalized due to lack of efficacy. The remaining patients hospitalized were admitted for reasons other than gastroenteritis.
Time frame: Day 1 of Study - Day 5 of Study
Number of Patients Returning to Emergency Department - ITT Population
Proportion of patients returning to emergency department for gastrointestinal symptoms within 4 days of initial discharge
Time frame: Day 1 of Study - Day 5 of Study