Trial · NCT05876585
Clinical Trial to Investigate the Efficacy and Safety of Ondansetron (Danset - Adwia) Versus Placebo Plus the Standard of Care in the Treatment of Nausea and Vomiting in Adult Patients With Acute Gastroenteritis
NCT05876585, Phase 3, Unknown, Genuine Research Center, Egypt
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial to Investigate the Efficacy and Safety of Ondansetron (Danset - Adwia) Versus Placebo Plus the Standard of Care in the Treatment of Nausea and Vomiting in Adult Patients With Acute Gastroenteritis. Trials, record NCT05876585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05876585
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Clinical Trial to Investigate the Efficacy and Safety of Ondansetron (Danset - Adwia) Versus Placebo Plus the Standard of Care in the Treatment of Nausea and Vomiting in Adult Patients With Acute Gastroenteritis
- NCT number
- NCT05876585
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 126 participants, estimated
- Lead sponsor
- Genuine Research Center, Egypt
- Conditions
- Gastroenteritis
- Interventions
- Ondansetron 8 mg ampoule, Metoclopramide 10 mg ampoule
- First posted
- 2023-05-25
- Last updated
- 2024-09-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The proportion of patients experiencing complete control of nausea and vomiting | 6 hours after receiving the study medication | Measured by asking the patient hourly to assess their nausea and vomiting. |
| Primary | The proportion of patients experiencing complete control of nausea and vomiting | 24 hours after receiving the study medication | Measured by asking the patient hourly to assess their nausea and vomiting. |
| Primary | The proportions of patients who experienced nausea, vomiting, or retching. | 6 hours hours after receiving the study medication | Measured by asking the patient hourly to assess their nausea, vomiting, or retching. |
| Primary | The proportions of patients who experienced nausea, vomiting, or retching. | 24 hours after receiving the study medication | Measured by asking the patient hourly to assess their nausea, vomiting, or retching. |
| Primary | The proportion of patients who needed intravenous rehydration | 24 hours after receiving the study medication | Assessed as per physician's discretion |
| Primary | The proportion of patients who needed a rescue anti-emetic medication | 24 hours after receiving the study medication | Assessed as per physician's discretion |
| Primary | The duration of stay at the emergency room before discharge | From date of admission until the date of discharge, up to 3 hours | The duration from admission to discharge from the emergency room |
| Primary | Overall patient's and physician's satisfaction with the efficacy of the study medication | 24 hours after receiving the study medication | Measured by asking the patient and the physician |
| Secondary | The number of adverse events and serious adverse events | 24 hours after receiving the study medication | Comparison between the number of adverse events and serious adverse events reported in the ondansetron 8 mg group and the metoclopramide 10 mg group |
| Secondary | Overall patient's satisfaction with the tolerability of the study medication | 24 hours after receiving the study medication | Measured by asking the patient |
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/NCT05876585
GET https://conductscience.org/api/trials/v1/NCT05876585/registered