BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis
GUARD
Randomized, Placebo-Controlled, Phase 3 Trial of BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis (The GUARD Study)
1 other identifier
interventional
330
1 country
26
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 (BEKINDA) in treating Acute Gastroenteritis, by comparing it to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2014
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2014
CompletedFirst Posted
Study publicly available on registry
September 22, 2014
CompletedStudy Start
First participant enrolled
December 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 16, 2017
CompletedResults Posted
Study results publicly available
February 20, 2019
CompletedFebruary 20, 2019
January 1, 2019
2.2 years
September 16, 2014
November 30, 2018
January 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
24 Hours
Secondary Outcomes (10)
Responders Through 4 Days After First Dose of Study Medication - ITT Population
4 Days
Number of Participants Who Vomited - ITT Population
24 Hours
Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population
24 Hours
Number of Patients Receiving Intravenous Fluids - ITT Population
24 Hours
Severity of Nausea at Baseline - ITT Population
Day 1 - Baseline through 5 Hours Post Dose
- +5 more secondary outcomes
Other Outcomes (2)
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication by Baseline Nausea Severity - ITT Population, All Ages
24 Hours
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population
24 Hours
Study Arms (2)
RHB-102
EXPERIMENTALRHB-102, Bimodal Release Ondansetron Tablets
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Kern Medical Center
Bakersfield, California, 93311, United States
UC Davis
Sacramento, California, 95817, United States
Olive View- UCLA Medical Center
Sylmar, California, 91342, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
University of Florida Jacksonville
Jacksonville, Florida, 32209, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
South Shore Hospital
South Weymouth, Massachusetts, 02190, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Wayne State University - Sinai Grace Hospital
Detroit, Michigan, 48235, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Washington University - St. Louis
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Kings County Hospital
Brooklyn, New York, 11203, United States
University Hospital of Brooklyn
Brooklyn, New York, 11203, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Cohen's Children's Medical Center of NY
New Hyde Park, New York, 11040, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Staten Island University Hospital North
Staten Island, New York, 10305, United States
Stony Brook University
Stony Brook, New York, 11794, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
UPMC Mercy
Pittsburgh, Pennsylvania, 15219, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
CityDoc Urgent Care
Dallas, Texas, 75209, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
McAllen Primary Care
McAllen, Texas, 78503, United States
Related Publications (1)
Silverman RA, House SL, Meltzer AC, Hahn B, Lovato LM, Avarello J, Miller JB, Kalfus IN, Fathi R, Raday G, Plasse TF, Yan EC. Bimodal Release Ondansetron for Acute Gastroenteritis Among Adolescents and Adults: A Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914988. doi: 10.1001/jamanetworkopen.2019.14988.
PMID: 31702802DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Terry Plasse
- Organization
- RedHill Biopharma Ltd.
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Silverman, MD
Long Island Jewish Hospital (LIJ)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2014
First Posted
September 22, 2014
Study Start
December 8, 2014
Primary Completion
February 13, 2017
Study Completion
February 16, 2017
Last Updated
February 20, 2019
Results First Posted
February 20, 2019
Record last verified: 2019-01