AzTrials
AzTrials

GastroenteritisPhase 3GUARDNCT02246439

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

A Phase 3 study testing RHB-102 in people with Gastroenteritis and Gastritis, run by RedHill Biopharma Limited at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 to 85 years
Conditions the study is for
Gastroenteritis, Gastritis
What is being tested?
RHB-102
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
330 participants
Where
26 sitesUnited States
Study dates
8 Dec 2014to 16 Feb 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • Kern Medical Center

    Bakersfield, California, 93311

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Kings County Hospital

    Brooklyn, New York, 11203

  • University Hospital of Brooklyn

    Brooklyn, New York, 11203

  • CityDoc Urgent Care

    Dallas, Texas, 75209

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Wayne State University - Sinai Grace Hospital

    Detroit, Michigan, 48235

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Florida Jacksonville

    Jacksonville, Florida, 32209

  • North Shore University Hospital

    Manhasset, New York, 11030

  • McAllen Primary Care

    McAllen, Texas, 78503

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Cohen's Children's Medical Center of NY

    New Hyde Park, New York, 11040

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • UPMC Mercy

    Pittsburgh, Pennsylvania, 15219

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15261

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • UC Davis

    Sacramento, California, 95817

  • South Shore Hospital

    South Weymouth, Massachusetts, 02190

  • Washington University - St. Louis

    St Louis, Missouri, 63110

  • Staten Island University Hospital North

    Staten Island, New York, 10305

  • Stony Brook University

    Stony Brook, New York, 11794

  • Olive View- UCLA Medical Center

    Sylmar, California, 91342

  • George Washington University

    Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
RHB-102, Placebo Oral Tablet
Keywords
Gastroenteritis, Gastritis, Vomiting, Nausea, Diarrhea
Medical subject headings
Gastroenteritis, Gastritis, Vomiting, Nausea, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RHB-102Drug

    RHB-102, Bimodal Release Ondansetron Tablets

  • Placebo Oral TabletDrug

    Also called Placebo

    Placebo

Study groups in NCT02246439
Study groupRoleWhat they receive
RHB-102ExperimentalRHB-102, Bimodal Release Ondansetron Tablets
Receives: Drug: RHB-102
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 Hours

Secondary outcomes (10)

  1. 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.

    Measured: 4 Days

  2. 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

    Measured: 24 Hours

  3. Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population

    Patients receiving rescue antiemetic therapy within 24 hours after the first dose of study medication.

    Measured: 24 Hours

  4. Number of Patients Receiving Intravenous Fluids - ITT Population

    Patients receiving parenteral hydration within 24 hours after the first dose of study medication.

    Measured: 24 Hours

  5. 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.

    Measured: Day 1 - Baseline through 5 Hours Post Dose

  6. Incidence and Severity of Diarrhea - ITT Population

    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.

    Measured: From 30 Minutes Through 24 Hours after First Dose of Study Medication

  7. 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.

    Measured: Hours from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last

  8. 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).

    Measured: Hours from first dose of study medication to resumption of normal activities

  9. 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.

    Measured: Day 1 of Study - Day 5 of Study

  10. 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

    Measured: Day 1 of Study - Day 5 of Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2014 (estimated)
  2. Study start8 Dec 2014
  3. Primary completion13 Feb 2017
  4. Study completion16 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02246439
Sponsor's protocol ID
RHB-102-01
Acronym
GUARD
Status last verified
Jan 2019
First submitted
16 Sep 2014
Last updated
20 Feb 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 31702802

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RHB-102 in people with Gastroenteritis and Gastritis, run by RedHill Biopharma Limited at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population (time frame: 24 Hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02246439, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in