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Trial record 10 of 12 for:    RedHill Biopharma

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

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ClinicalTrials.gov Identifier: NCT02246439
Recruitment Status : Completed
First Posted : September 22, 2014
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
RedHill Biopharma Limited

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.


Condition or disease Intervention/treatment Phase
Gastroenteritis Gastritis Drug: RHB-102 Drug: Placebo Oral Tablet Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 (The GUARD Study)
Actual Study Start Date : December 8, 2014
Actual Primary Completion Date : February 13, 2017
Actual Study Completion Date : February 16, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RHB-102
RHB-102, Bimodal Release Ondansetron Tablets
Drug: RHB-102
RHB-102, Bimodal Release Ondansetron Tablets

Placebo Comparator: Placebo
Placebo
Drug: Placebo Oral Tablet
Placebo
Other Name: Placebo




Primary Outcome Measures :
  1. Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population [ Time Frame: 24 Hours ]
    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


Secondary Outcome Measures :
  1. Responders Through 4 Days After First Dose of Study Medication - ITT Population [ Time Frame: 4 Days ]
    Treatment success, as defined in the primary outcome, through 4 days following first dose of study medication.

  2. Number of Participants Who Vomited - ITT Population [ Time Frame: 24 Hours ]
    Analysis of vomiting from 30 minutes after first administration of study medication until 24 hours post first dose

  3. Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population [ Time Frame: 24 Hours ]
    Patients receiving rescue antiemetic therapy within 24 hours after the first dose of study medication.

  4. Number of Patients Receiving Intravenous Fluids - ITT Population [ Time Frame: 24 Hours ]
    Patients receiving parenteral hydration within 24 hours after the first dose of study medication.

  5. Severity of Nausea at Baseline - ITT Population [ Time Frame: Day 1 - Baseline through 5 Hours Post Dose ]
    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.

  6. Incidence and Severity of Diarrhea - ITT Population [ Time Frame: From 30 Minutes Through 24 Hours after First Dose of Study Medication ]
    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.

  7. Time to Discharge From Emergency Department (ED), Extended Observation Unit, or Hospital - ITT Population [ Time Frame: Hours from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last ]
    Time from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last, and when clinically appropriate.

  8. Time to Resumption of Normal Activities (Work/School/Household) - ITT Population [ Time Frame: Hours from first dose of study medication to resumption of normal activities ]
    Time from first dose of study medication to resumption of normal activities (work/school/household).

  9. Number of Patients Requiring Hospitalization - ITT Population [ Time Frame: Day 1 of Study - Day 5 of Study ]
    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.

  10. Number of Patients Returning to Emergency Department - ITT Population [ Time Frame: Day 1 of Study - Day 5 of Study ]
    Proportion of patients returning to emergency department for gastrointestinal symptoms within 4 days of initial discharge


Other Outcome Measures:
  1. Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication by Baseline Nausea Severity - ITT Population, All Ages [ Time Frame: 24 Hours ]
    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

  2. Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population [ Time Frame: 24 Hours ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 85 Years   (Child, Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246439


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

Documents provided by RedHill Biopharma Limited:
Study Protocol  [PDF] June 9, 2016
Statistical Analysis Plan  [PDF] May 29, 2017


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Responsible Party: RedHill Biopharma Limited
ClinicalTrials.gov Identifier: NCT02246439     History of Changes
Other Study ID Numbers: RHB-102-01
First Posted: September 22, 2014    Key Record Dates
Results First Posted: February 20, 2019
Last Update Posted: February 20, 2019
Last Verified: January 2019

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

Additional relevant MeSH terms:
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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