Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)

June 24, 2014 updated by: Dr. Graham Thompson

Comparison of Ondansetron Oral Solution to Orally Disintegrating Tablets for the Management of Suspected Viral Gastroenteritis in a Pediatric Emergency Department

In children aged 3 months to 10 years who present to the Pediatric Emergency Department (PED) with recent, significant vomiting and moderate dehydration, is treatment with Ondansetron Orally Disintegrating Tablet (ODT) better tolerated than treatment with Ondansetron Oral Solution (OS)? Our hypothesis is that children who receive Ondansetron ODT will have 10% less vomiting within 15 minutes of administration than those receiving Ondansetron OS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Vomiting related to viral gastroenteritis is the most common presentation to the Alberta Children's Hospital Pediatric Emergency Department. Recently, a clinical pathway was implemented to improve the care and flow of patients with vomiting and/or diarrhea through the department. Administration of an antiemetic, Ondansetron, is an integral part of improving the hydration status of children managed by the pathway. However it is not know whether Oral Solution or Oral Disintegrating Tablets are better tolerated in children who have active vomiting. The investigators aim to show that children receiving Oral Disintegrating Tablets have less vomiting immediately after medication administration than children receiving Oral Solution. By demonstrating this improved tolerability the investigators will provide health care providers the stimulus for implementing Ondansetron Oral Disintegrating Tablets into their practice for children with active vomiting.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
462

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 months to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Alberta Children's Hospital Emergency department, all patients presenting with acute gastroenteritis

Description

Inclusion Criteria:

  • Children aged 3 months to 10 years with recent,
  • significant vomiting and moderate dehydration who are managed according to the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting & Diarrhea Pathway.
  • The following definitions are used to determine inclusion according to the pathway: Recent, significant vomiting - Vomiting at least 6 episodes in the past 6 hours and at least once in the past hour; Moderate dehydration (Gorelick Score 2) - Two of the following: capillary refill time greater than 2 seconds, absence of tears, dry mucous membranes, ill general appearance.

Exclusion Criteria:

  • Children who are excluded from the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting & Diarrhea Pathway.
  • These criteria include: Vomiting or Diarrhea for greater than 7 days, Localized abdominal pain, Chronic medical conditions affecting major organ systems (Ex, diabetes, PKU, immunodeficiency), Likely GI Obstruction (abdominal distension, bilious vomiting, absent bowel sounds), Weight less than 8kg. Children who have received anti-emetics at home will not be excluded but will be tracked.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Oral Ondansetron
Arm that receive oral solution .8 mgms per ml ondansetron - Apotex Brand DIN 02291967
Oral disintegrating tablets
Arm that receives the disintegrating tablets either 4mg or 8 mgs Glaxo Brand 4 mg DIN 02239372, 8 mg DIN 02239373

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
proportion of patients who vomit within 15 minutes of administration of anti-emetic
Time Frame: 15 minutes
To determine the proportion of patients aged 3 months to 10 years who present to the PED with recent significant vomiting and moderate dehydration who vomit within 15 minutes of receiving either Ondansetron Oral Solution versus Orally Disintegrating Tablets.
15 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
# episodes of vomiting after ondansetron administration
Time Frame: While in the ED, anticipated to be on average < 5 hours
To determine the number of episodes of vomiting while in the emergency department (after Ondansetron administration) that are experienced by the above population.
While in the ED, anticipated to be on average < 5 hours
Discharged home without IV
Time Frame: Duration of ED visit, anticipated to be on average < 5 hours
To determine the proportions of children in each study group that are discharged home from the Emergency Department without receiving IV fluids.
Duration of ED visit, anticipated to be on average < 5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Graham Thompson

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Graham Thompson, Physician, Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary
  • Principal Investigator: David W Johnson, Physician, Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OND - 0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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