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5-HT3 Receptor Antagonist

Oral Ondansetron for Stomach Flu (DOSE-AGE Trial)

Phase 3

Recruiting

Led By Stephen Freedman, MD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A minimum of 1 episode of vomiting within 6 hours of the screening process performed by the research team

A minimum of 1 dose of ondansetron (oral or intravenous) provided during the current emergency department visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured 24, 48, and 168 hours after baseline visit

Awards & highlights

DOSE-AGE Trial Summary

This trial is testing whether the drug Ondansetron is effective in treating vomiting caused by gastroenteritis.

Who is the study for?

This trial is for kids and teens aged 6 months to nearly 18 years with a stomach bug causing vomiting and diarrhea, who've had at least one ondansetron dose in the ER. They must have vomited three times in the last day but been sick for less than three days. Kids allergic to ondansetron or its ingredients, with certain genetic conditions like G6PD deficiency, heart issues, or taking specific drugs can't join.Check my eligibility

What is being tested?

The study tests if multiple doses of an oral solution called Ondansetron can help children stop vomiting after they leave the ER due to a stomach flu. It's compared against a placebo (a dummy treatment) to see which works better.See study design

What are the potential side effects?

Ondansetron might cause headaches, constipation or diarrhea, fatigue, changes in how things taste and rare serious effects like heart rhythm changes. The side effects vary from person to person.

DOSE-AGE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have vomited at least once within 6 hours of being screened.

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I received at least one dose of ondansetron during my current ER visit.

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My doctor confirmed I have an acute intestinal infection.

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I have vomited 3 or more times in the last 24 hours.

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I am between 6 months and 17 years old.

DOSE-AGE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 168 hours after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~168 hours after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 168 hours after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Development of moderate to severe disease as defined by the Modified Vesikari Scale (MVS) Score of ≥ 9 following ED evaluation - change in the MVS score between Hour 0 and Hour 168 of the study.

Secondary outcome measures

Proportion of participants who require Intravenous (IV) Rehydration

Proportion of participants who require an unscheduled health care visit

Satisfaction with care: 5 point Likert Scale

+3 more

Other outcome measures

Safety Profile of Multiple Doses of Oral Ondansetron

DOSE-AGE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ondansetron Oral SolutionExperimental Treatment1 Intervention

Ondansetron Oral Solution (4mg/5mL solution) - Dose = 0.15mg/kg. One dose every 8 hours (q8h). Six doses over 48 hours.

Group II: Placebo Oral SolutionPlacebo Group1 Intervention

Compounded Placebo Oral Solution to match experimental arm

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Université de MontréalOTHER

214 Previous Clinical Trials

101,741 Total Patients Enrolled

University of CalgaryLead Sponsor

792 Previous Clinical Trials

868,124 Total Patients Enrolled

University of OttawaOTHER

207 Previous Clinical Trials

266,111 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will this research be open to elderly participants?

"This trial is open to children that are a minimum 6 months old and no older than 17 years old."

Answered by AI

For what purpose is Ondansetron Oral Solution most commonly prescribed?

"The standard course of treatment for uremia is Ondansetron Oral Solution. This medication can also bring relief to patients experiencing nausea and vomiting as a result of radiation therapy, those going through pharmacotherapy, and people suffering from pruritus."

Answered by AI

Is Ondansetron Oral Solution a danger to anyone who takes it?

"Ondansetron Oral Solution received a score of 3 because there is evidence from previous clinical trials to support its efficacy and safety."

Answered by AI

What is the body of evidence for Ondansetron Oral Solution?

"Ondansetron Oral Solution was first evaluated in 2014 by researchers at harbin Medical University. There have been a total of 234 completed clinical trials to date, with 24 more currently underway. The majority of these ongoing trials are located in Edmonton, Alberta."

Answered by AI

How many patients are selected for this research project?

"This study needs 1030 individuals who match the required profile. These potential participants can be sourced from different hospitals, like Stollery Children's Hospital in Edmonton, Alberta and Alberta Children's Hospital in Calgary, Manitoba."

Answered by AI

Recent research and studies

TrialsJournal

Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: Study Protocol for the Multi-dose Oral Ondansetron for Pediatric Acute Gastroenteritis (DOSE-AGE) Pragmatic Randomized Controlled Trial

Freedman, Stephen B., on behalf of the KidsCAN-Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials DOSE-AGE Study Group, Sarah Williamson-Urquhart, Anna Heath, Petros Pechlivanoglou, Gareth Hopkin, Serge Gouin, et al.. 2020. “Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: Study Protocol for the Multi-dose Oral Ondansetron for Pediatric Acute Gastroenteritis (DOSE-AGE) Pragmatic Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-020-04347-6.

TrialsJournal

A Pragmatic Randomized Controlled Trial of Multi-dose Oral Ondansetron for Pediatric Gastroenteritis (the DOSE-AGE Study): Statistical Analysis Plan

Heath, Anna, Juan David Rios, Sarah Williamson-Urquhart, Petros Pechlivanoglou, Martin Offringa, Christopher McCabe, Gareth Hopkin, et al.. 2020. “A Pragmatic Randomized Controlled Trial of Multi-dose Oral Ondansetron for Pediatric Gastroenteritis (the DOSE-AGE Study): Statistical Analysis Plan”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-020-04651-1.

clinicaltrials.govStudy

Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis

2019. "Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03851835.

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