Acute GastroenteritisPhase 3DOSE-AGENCT03851835
Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis
A Phase 3 study testing Ondansetron Oral Solution in people with Acute Gastroenteritis and Viral Illness, run by University of Calgary at 6 sites in Canada.
Trial summary
A phase III, double-blind, parallel-design, randomized, placebo-controlled trial to compare multi-dose oral Ondansetron with placebo as treatment for vomiting secondary to acute gastroenteritis (AGE), after Emergency Department discharge. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Acute Gastroenteritis, Viral Illness, Vomiting
- What is being tested?
- Ondansetron Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,030 participants
- Where
- 6 sitesCanada
- Study dates
- 14 Sep 2019to 6 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Willingness to comply with all study procedures and availability for the duration of the study.
- Diagnosis of acute intestinal infectious process (as defined by the protocol) confirmed. by the treating physician.
- Age 6 months to 17.99 years.
- Presence of ≥ 3 episodes of vomiting in the preceding 24-hour period.
- Duration of vomiting and/or diarrheal symptoms < 72 hours.
- 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.
Who cannot join
- Bilious or bloody vomit during current illness.
- Known hypersensitivity to ondansetron or any serotonin receptor antagonist (e.g. palonosetron, dolasetron, granisetron).
- Known allergic reaction to components of ondansetron (citric acid, sodium benzoate, sodium citrate dihydrate, and strawberry flavor, sorbitol) or the placebo medication (methylparaben, glycerin, citric acid, potassium sorbate, sorbitol, strawberry flavor).
- History or family history (first degree relative) of prolonged QT syndrome.
- Presence of complex congenital heart disease.
- History or family history (first degree relative) of cardiac arrhythmia.
Show all 10Show fewer
- Concomitant use (within the past 48 hours) of any of the following: QTc prolonging medications, medications known to cause torsades de pointes, medications that cause electrolyte abnormalities, serotonergic or neuroleptic medications, or any 5-HT3 receptor antagonist excluding ondansetron.
- Unable to complete follow-up.
- Previously enrolled in this study.
- History or family history of G6PD deficiency.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Stollery Children's Hospital
Edmonton, Alberta, T6G 2C8
Children's Hospital London Health Sciences Centre
London, Ontario, N6A 5W9
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec, HT3 1C5
Children's Hospital of Eastern Ontario (CHEO)
Ottawa, Ontario, K1H 8L1
Children's Hospital of Winnipeg
Winnipeg, Manitoba, R3A 1S1
About this study
Official title: Multi-dose Oral Ondansetron For Pediatric Gastroenteritis: A Pragmatic Randomized Controlled Trial
A phase III, double-blind, parallel-design, randomized, placebo-controlled trial to compare multi-dose oral Ondansetron with placebo as treatment for vomiting secondary to acute gastroenteritis (AGE), after Emergency Department discharge.
Read the detailed description
The annual burden of acute gastroenteritis in the United States includes 17 million related episodes and 473,832 hospitalizations. Although oral-rehydration therapy is recommended for children with mild-to-moderate dehydration, it has historically been underused with emergency department (ED) clinicians being more likely to choose intravenous over oral rehydration especially when vomiting is a major symptom. In fact, nearly 95% of children undergoing oral rehydration in Canadian EDs present with recent vomiting. To address this issue, the investigators conducted both a landmark clinical trial and a recent meta-analysis that have demonstrated that the ED use of ondansetron, an anti-emetic, leads to reductions in intravenous rehydration and hospitalization and is cost-effective. However, the available data revealed some associations with increased diarrhea and no evidence of benefits associated with ongoing ondansetron use following ED discharge. Despite the lack of available data, the provision of multiple doses of ondansetron for home use has become routine in many EDs across North America. The literature has differing opinions on the topic of ongoing ondansetron use after ED discharge and given the limited evidence supporting its use, the potential side effects and additional cost, there is an urgent need to definitively evaluate the effect of multiple doses of ondansetron in children, focusing on family-centred, post-index visit outcomes.
A phase III, double-blind, parallel-design, randomized, placebo controlled trial to compare multi-dose oral Ondansetron with placebo as treatment for vomiting secondary to acute gastroenteritis (AGE), after Emergency Department discharge will be conducted. Children and youth, age 6 months to 17.99 years will be enrolled at six (6) Canadian Emergency Departments. The total number of participants recruited will be 1030. Participants will be enrolled at six (6) pediatric emergency departments across Canada.
Children who are provided a minimum of one dose of ondansetron as part of their routine clinical care AND meet other eligibility criteria will be randomized to receive an at-home kit with six (6) doses of Ondansetron Hydrochloride Dihydrate Oral Solution (4mg/5mL solution; dosed at 0.15mg/kg to a maximum single dose of 8mg) or equivalent volume in a Placebo Oral Solution to be administered no sooner than 8 hours after the initial clinical dose was provided by the ED physician. Over the subsequent 48 hours, the study intervention will be administered at a rate of 1 dose every 8 hours (q8h) to a maximum of 3 doses a day (in a 24-hour period (TID)) at the caregiver's discretion. Two (2) additional doses will be provided to the caregiver in case the child vomits a dose.
- Conditions
- Acute Gastroenteritis, Viral Illness, Vomiting, Diarrhea
- Being tested
- Ondansetron Oral Solution, Oral Placebo
- Keywords
- Vomiting, Zofran, Ondansetron, Gastroenteritis, Pediatrics, DOSE-AGE
- Medical subject headings
- Virus Diseases, Vomiting, Diarrhea, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron Oral SolutionDrug
Also called Zofran
Six doses of oral ondansetron (0.15mg/kg) to be administered q8h (every 8 hours) to a maximum of 3 times in a 24 hour period, are provided to the participant/caregiver for use after emergency department disposition (i.e. home use), as needed.
Oral PlaceboDrug
Six doses of oral placebo (0.15mg/kg) to be administered q8h (every 8 hours) to a maximum of 3 times in a 24-hour period, are provided to the participant/caregiver for use after emergency department disposition (i.e. home use), as needed.
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron Oral Solution | Experimental | Ondansetron Oral Solution (4mg/5mL solution) - Dose = 0.15mg/kg. One dose every 8 hours (q8h), as needed. Up to a maximum of six doses over 48 hours. Receives: Drug: Ondansetron Oral Solution |
| Placebo Oral Solution | Placebo comparator | Compounded Placebo Oral Solution to match experimental arm Receives: Drug: Oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The Modified Vesikari Scale Score (MVS) is a composite measure which includes several variables representing the severity of disease - points are summed to provide an overall score:
- Duration of diarrhea (hours): 0 (0 points), 1-96 (1 point), 97-120 (2 points), ≥121 (3 points)
- Maximum number of watery stools per 24 hour period: 0 (0 points), 1-3 (1 point), 4-5 (2 points), ≥6 (3 points)
- Duration of vomiting (hours): 0 (0 points), 1-24 (1 point), 25-48 (2 points), ≥49 (3 points)
- Maximum number of vomiting episodes per 24 hour period: none (0 points), 1 (1 point), 2-3 (2 points), ≥5 (3 points).
- Maximum recorded rectal temperature (degrees Celsius): <37.0 (0 points), 37.1-38.4 (1 point), 38.5-38.9 (2 points), ≥39.0 (3 points)
- Unscheduled health care visit: None (0 points), Primary Care (2 points), emergency department (3 points)
- Treatment: None (0 points), Rehydration with IV fluids (1 point), Hospitalization (2 points)
Measured: Measured 24, 48, and 168 hours after baseline visit
Secondary outcomes (6)
Vomiting Duration
Number of hours of vomiting following ED disposition.
Measured: Measured 24, 48, and 168 hours after baseline visit
Vomiting Frequency
Number of episodes of vomiting following ED disposition.
Measured: Measured 24, 48, and 168 hours after baseline visit
Vomiting Proportion
The proportion who experience vomiting following ED disposition.
Measured: Measured 24, 48, and 168 hours after baseline visit
Proportion of participants who require an unscheduled health care visit
Unscheduled health care provider visits following Emergency Department disposition. Is there a difference in the proportion who require an unscheduled health care provider visit following ED disposition.
Measured: Measured 24, 48, and 168 hours after baseline visit
Proportion of participants who require Intravenous (IV) Rehydration
Is there a difference in the proportion who require intravenous rehydration following ED disposition.
Measured: Measured 24, 48, and 168 hours after baseline visit
Satisfaction with care: 5 point Likert Scale
Caregivers will be asked about their level of satisfaction with the therapy provided measured on the following 5 point Likert scale (choose one option):
- 1 - Very dissatisfied
- 2 - Dissatisfied
- 3 - Neither satisfied, nor dissatisfied
- 4 - Satisfied
- 5 - Very Satisfied
Measured: 168 hours after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start14 Sep 2019
- Primary completion27 Jun 2024
- Study completion6 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute GastroenteritisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Women and Children's Health Research Institute, Canada, The Hospital for Sick Children, Children's Hospital Research Institute of Manitoba, University of Manitoba, Université de Montréal, University of Ottawa, University of Alberta, Alberta Children's Hospital Research Institute, Western University, Canada
- Responsible party
- Sponsor
- Investigators
- Stephen Freedman, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851835
- Sponsor's protocol ID
- OND18-2045
- Acronym
- DOSE-AGE
- Status last verified
- Apr 2025
- First submitted
- 19 Feb 2019
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sumner M, Xie J, Williamson-Urquhart S, Plint AC, Dixon A, Beer D, Joubert G, Finkelstein Y, Pechlivanoglou P, Klassen T, Freedman SB; Pediatric Emergency Research Canada (PERC). Persistent Vomiting Among Children With Acute Gastroenteritis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2610898. doi: 10.1001/jamanetworkopen.2026.10898.
PubMed 42090154Freedman SB, Williamson-Urquhart S, Plint AC, Dixon A, Beer D, Joubert G, Pechlivanoglou P, Finkelstein Y, Heath A, Zhang JZ, Wallace A, Offringa M, Klassen TP; Pediatric Emergency Research Canada Innovative Clinical Trials Study Group. Multidose Ondansetron after Emergency Visits in Children with Gastroenteritis. N Engl J Med. 2025 Jul 17;393(3):255-266. doi: 10.1056/NEJMoa2503596.
PubMed 40673584Heath A, Rios JD, Williamson-Urquhart S, Pechlivanoglou P, Offringa M, McCabe C, Hopkin G, Plint AC, Dixon A, Beer D, Gouin S, Joubert G, Klassen TP, Freedman SB; PERC-KIDSCAN DOSE-AGE Study Group. A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan. Trials. 2020 Aug 24;21(1):735. doi: 10.1186/s13063-020-04651-1.
PubMed 32838813Freedman SB, Williamson-Urquhart S, Heath A, Pechlivanoglou P, Hopkin G, Gouin S, Plint AC, Dixon A, Beer D, Joubert G, McCabe C, Finkelstein Y, Klassen TP; KidsCAN-Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials DOSE-AGE Study Group. 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. 2020 May 27;21(1):435. doi: 10.1186/s13063-020-04347-6.
PubMed 32460879
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-dose Oral Ondansetron For Pediatric Gastroenteritis: A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03851835
- Acronym / sponsor ID
- DOSE-AGE / OND18-2045
- Conditions
- Acute Gastroenteritis, Viral Illness, Vomiting, Diarrhea
- Keywords
- Vomiting, Zofran, Ondansetron, Gastroenteritis, Pediatrics, DOSE-AGE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,030 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Women and Children's Health Research Institute, Canada, The Hospital for Sick Children, Children's Hospital Research Institute of Manitoba, University of Manitoba, Université de Montréal, University of Ottawa, University of Alberta, Alberta Children's Hospital Research Institute, Western University, Canada
- Study start
- 14 Sep 2019 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 6 Jul 2024 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase III, double-blind, parallel-design, randomized, placebo-controlled trial to compare multi-dose oral Ondansetron with placebo as treatment for vomiting secondary to acute gastroenteritis (AGE), after Emergency Department discharge.
Detailed description
The annual burden of acute gastroenteritis in the United States includes 17 million related episodes and 473,832 hospitalizations. Although oral-rehydration therapy is recommended for children with mild-to-moderate dehydration, it has historically been underused with emergency department (ED) clinicians being more likely to choose intravenous over oral rehydration especially when vomiting is a major symptom. In fact, nearly 95% of children undergoing oral rehydration in Canadian EDs present with recent vomiting. To address this issue, the investigators conducted both a landmark clinical trial and a recent meta-analysis that have demonstrated that the ED use of ondansetron, an anti-emetic, leads to reductions in intravenous rehydration and hospitalization and is cost-effective. However, the available data revealed some associations with increased diarrhea and no evidence of benefits associated with ongoing ondansetron use following ED discharge. Despite the lack of available data, the provision of multiple doses of ondansetron for home use has become routine in many EDs across North America. The literature has differing opinions on the topic of ongoing ondansetron use after ED discharge and given the limited evidence supporting its use, the potential side effects and additional cost, there is an urgent need to definitively evaluate the effect of multiple doses of ondansetron in children, focusing on family-centred, post-index visit outcomes.
A phase III, double-blind, parallel-design, randomized, placebo controlled trial to compare multi-dose oral Ondansetron with placebo as treatment for vomiting secondary to acute gastroenteritis (AGE), after Emergency Department discharge will be conducted. Children and youth, age 6 months to 17.99 years will be enrolled at six (6) Canadian Emergency Departments. The total number of participants recruited will be 1030. Participants will be enrolled at six (6) pediatric emergency departments across Canada.
Children who are provided a minimum of one dose of ondansetron as part of their routine clinical care AND meet other eligibility criteria will be randomized to receive an at-home kit with six (6) doses of Ondansetron Hydrochloride Dihydrate Oral Solution (4mg/5mL solution; dosed at 0.15mg/kg to a maximum single dose of 8mg) or equivalent volume in a Placebo Oral Solution to be administered no sooner than 8 hours after the initial clinical dose was provided by the ED physician. Over the subsequent 48 hours, the study intervention will be administered at a rate of 1 dose every 8 hours (q8h) to a maximum of 3 doses a day (in a 24-hour period (TID)) at the caregiver's discretion. Two (2) additional doses will be provided to the caregiver in case the child vomits a dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron Oral Solution | Experimental | Drug: Ondansetron Oral SolutionOndansetron Oral Solution (4mg/5mL solution) - Dose = 0.15mg/kg. One dose every 8 hours (q8h), as needed. Up to a maximum of six doses over 48 hours. |
| Placebo Oral Solution | Placebo comparator | Drug: Oral PlaceboCompounded Placebo Oral Solution to match experimental arm |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Willingness to comply with all study procedures and availability for the duration of the study.
- Diagnosis of acute intestinal infectious process (as defined by the protocol) confirmed. by the treating physician.
- Age 6 months to 17.99 years.
- Presence of ≥ 3 episodes of vomiting in the preceding 24-hour period.
- Duration of vomiting and/or diarrheal symptoms < 72 hours.
Key exclusion criteria (10 listed)
- Bilious or bloody vomit during current illness.
- Known hypersensitivity to ondansetron or any serotonin receptor antagonist (e.g. palonosetron, dolasetron, granisetron).
- Known allergic reaction to components of ondansetron (citric acid, sodium benzoate, sodium citrate dihydrate, and strawberry flavor, sorbitol) or the placebo medication (methylparaben, glycerin, citric acid, potassium sorbate, sorbitol, strawberry flavor).
- History or family history (first degree relative) of prolonged QT syndrome.
- Presence of complex congenital heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetron Oral SolutionAlso: ZofranSix doses of oral ondansetron (0.15mg/kg) to be administered q8h (every 8 hours) to a maximum of 3 times in a 24 hour period, are provided to the participant/caregiver for use after emergency department disposition (i.e. home use), as needed. | Drug | Ondansetron Oral Solution |
| Oral PlaceboSix doses of oral placebo (0.15mg/kg) to be administered q8h (every 8 hours) to a maximum of 3 times in a 24-hour period, are provided to the participant/caregiver for use after emergency department disposition (i.e. home use), as needed. | Drug | Placebo Oral Solution |
Primary outcome
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.
Time frame: Measured 24, 48, and 168 hours after baseline visit
The Modified Vesikari Scale Score (MVS) is a composite measure which includes several variables representing the severity of disease - points are summed to provide an overall score: * Duration of diarrhea (hours): 0 (0 points), 1-96 (1 point), 97-120 (2 points), ≥121 (3 points) * Maximum number of watery stools per 24 hour period: 0 (0 points), 1-3 (1 point), 4-5 (2 points), ≥6 (3 points) * Duration of vomiting (hours): 0 (0 points), 1-24 (1 point), 25-48 (2 points), ≥49 (3 points) * Maximum number of vomiting episodes per 24 hour period: none (0 points), 1 (1 point), 2-3 (2 points), ≥5 (3 points). * Maximum recorded rectal temperature (degrees Celsius): <37.0 (0 points), 37.1-38.4 (1 point), 38.5-38.9 (2 points), ≥39.0 (3 points) * Unscheduled health care visit: None (0 points), Primary Care (2 points), emergency department (3 points) * Treatment: None (0 points), Rehydration with IV fluids (1 point), Hospitalization (2 points)
6 secondary outcomes
Vomiting Duration
Time frame: Measured 24, 48, and 168 hours after baseline visit
Vomiting Frequency
Time frame: Measured 24, 48, and 168 hours after baseline visit
Vomiting Proportion
Time frame: Measured 24, 48, and 168 hours after baseline visit
Proportion of participants who require an unscheduled health care visit
Time frame: Measured 24, 48, and 168 hours after baseline visit
Proportion of participants who require Intravenous (IV) Rehydration
Time frame: Measured 24, 48, and 168 hours after baseline visit
Satisfaction with care: 5 point Likert Scale
Time frame: 168 hours after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Derived from this study: PubMed 42090154Sumner M, Xie J, Williamson-Urquhart S, Plint AC, Dixon A, Beer D, Joubert G, Finkelstein Y, Pechlivanoglou P, Klassen T, Freedman SB; Pediatric Emergency Research Canada (PERC). Persistent Vomiting Among Children With Acute Gastroenteritis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2610898. doi: 10.1001/jamanetworkopen.2026.10898.
- Derived from this study: PubMed 40673584Freedman SB, Williamson-Urquhart S, Plint AC, Dixon A, Beer D, Joubert G, Pechlivanoglou P, Finkelstein Y, Heath A, Zhang JZ, Wallace A, Offringa M, Klassen TP; Pediatric Emergency Research Canada Innovative Clinical Trials Study Group. Multidose Ondansetron after Emergency Visits in Children with Gastroenteritis. N Engl J Med. 2025 Jul 17;393(3):255-266. doi: 10.1056/NEJMoa2503596.
- Derived from this study: PubMed 32838813Heath A, Rios JD, Williamson-Urquhart S, Pechlivanoglou P, Offringa M, McCabe C, Hopkin G, Plint AC, Dixon A, Beer D, Gouin S, Joubert G, Klassen TP, Freedman SB; PERC-KIDSCAN DOSE-AGE Study Group. A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan. Trials. 2020 Aug 24;21(1):735. doi: 10.1186/s13063-020-04651-1.
- Derived from this study: PubMed 32460879Freedman SB, Williamson-Urquhart S, Heath A, Pechlivanoglou P, Hopkin G, Gouin S, Plint AC, Dixon A, Beer D, Joubert G, McCabe C, Finkelstein Y, Klassen TP; KidsCAN-Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials DOSE-AGE Study Group. 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. 2020 May 27;21(1):435. doi: 10.1186/s13063-020-04347-6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Freedman, MD principal investigator
University of Calgary
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ondansetron Oral Solution in people with Acute Gastroenteritis and Viral Illness, run by University of Calgary at 6 sites in Canada.
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 7 inclusion and 10 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 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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. (time frame: Measured 24, 48, and 168 hours after baseline visit). 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 NCT03851835, which also lists 4 linked publications.
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 25 Apr 2025.