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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) (GUARD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by RedHill Biopharma Limited
Sponsor:
Information provided by (Responsible Party):
RedHill Biopharma Limited
ClinicalTrials.gov Identifier:
NCT02246439
First received: September 16, 2014
Last updated: November 22, 2016
Last verified: November 2016
  Purpose

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.


Condition Intervention Phase
Gastroenteritis
Gastritis
Drug: RHB-102
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Placebo-Controlled, Phase 3 Trial of BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis

Resource links provided by NLM:


Further study details as provided by RedHill Biopharma Limited:

Primary Outcome Measures:
  • Proportion 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: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of vomiting [ Time Frame: Release from ED through 4 days post first dose ] [ Designated as safety issue: No ]
  • Proportion of patients receiving rescue antiemetic therapy [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Proportion of patients receiving intravenous fluids [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Proportion of patients requiring hospitalization [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Proportion of patients returning to emergency department for gastrointestinal symptoms [ Time Frame: Day1-4 ] [ Designated as safety issue: No ]
  • Severity of nausea, evaluated by Likert scales [ Time Frame: Day 1-4 ] [ Designated as safety issue: No ]
  • Incidence and frequency of diarrhea [ Time Frame: Day 1-4 ] [ Designated as safety issue: No ]
  • Adverse event profiles [ Time Frame: Day 1-4 ] [ Designated as safety issue: Yes ]
  • Time to resumption of normal activities (work/school/household) [ Time Frame: Days 1-4 ] [ Designated as safety issue: No ]
  • Time from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Time from first dose of study medication to first episode of vomiting [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: September 2014
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RHB-102
RHB-102, Bimodal Release Ondasetron Tablets
Drug: RHB-102
RHB-102, Bimodal Release Ondasetron Tablets
Placebo Comparator: Placebo
Placebo
Drug: RHB-102
RHB-102, Bimodal Release Ondasetron Tablets

  Eligibility

Ages Eligible for Study:   12 Years to 85 Years   (Child, Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02246439

Contacts
Contact: Joanna Murray, MBA, CCRP 434.473.6415 jmurray@atlanticresearchgroup.com
Contact: Gina Gualtiere, MSHS 434.227.5817 ggualtiere@atlanticresearchgroup.com

  Show 26 Study Locations
Sponsors and Collaborators
RedHill Biopharma Limited
Investigators
Principal Investigator: Robert Silverman, MD Long Island Jewish Hospital (LIJ)
  More Information

Responsible Party: RedHill Biopharma Limited
ClinicalTrials.gov Identifier: NCT02246439     History of Changes
Other Study ID Numbers: RHB-102-01 
Study First Received: September 16, 2014
Last Updated: November 22, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by RedHill Biopharma Limited:
Gastroenteritis
Gastritis
Vomiting
Nausea
Diarrhea

Additional relevant MeSH terms:
Vomiting
Gastroenteritis
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on January 17, 2017