Trial · NCT03851835
Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis
NCT03851835, Phase 3, Completed, University of Calgary
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis. Trials, record NCT03851835. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03851835
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis
- NCT number
- NCT03851835
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,030 participants, actual
- Lead sponsor
- University of Calgary
- Conditions
- Acute Gastroenteritis, Viral Illness, Vomiting, Diarrhea
- Interventions
- Ondansetron Oral Solution, Oral Placebo
- First posted
- 2019-02-22
- Last updated
- 2025-04-25
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | 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) |
| Secondary | Vomiting Duration | Measured 24, 48, and 168 hours after baseline visit | Number of hours of vomiting following ED disposition. |
| Secondary | Vomiting Frequency | Measured 24, 48, and 168 hours after baseline visit | Number of episodes of vomiting following ED disposition. |
| Secondary | Vomiting Proportion | Measured 24, 48, and 168 hours after baseline visit | The proportion who experience vomiting following ED disposition. |
| Secondary | Proportion of participants who require an unscheduled health care visit | Measured 24, 48, and 168 hours after baseline 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. |
| Secondary | Proportion of participants who require Intravenous (IV) Rehydration | Measured 24, 48, and 168 hours after baseline visit | Is there a difference in the proportion who require intravenous rehydration following ED disposition. |
| Secondary | Satisfaction with care: 5 point Likert Scale | 168 hours after baseline | 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 |
| Other | Safety Profile of Multiple Doses of Oral Ondansetron | Measured 24, 48, and 168 hours after baseline visit | To determine if the discharge of children with AGE associated vomiting who are administered ondansetron in the ED with additional doses to be taken at home is associated with adverse events (e.g. diarrhea, revisits) as compared with placebo. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03851835
GET https://conductscience.org/api/trials/v1/NCT03851835/registered