5-HT3 Antagonists (Antiemetics) and Cardiac Safety Using an Active Surveillance Approach
Completed NCT02436798
Study Description
5-HT3 antagonists (ondansetron) are highly effective medications for the treatment of nausea and vomiting. However, these medications also associated with potentially severe and life-threatening cardiac adverse drug reactions (ADRs), particularly QT prolongation. Data regarding the cardiac safety and inter-individual variability in cardiac effects of ondansetron when used in vulnerable populations such as children and pregnant women are very limited. The results of this study will enable better-informed therapeutic decision-making regarding the use of ondansetron in children and pregnant women, with the overall goal to improve the safety of these commonly used antiemetic medications. Furthermore, predictive pharmacogenetic markers of severe 5-HT3 antagonist toxicity could be used to identify patients at risk of cardiac toxicity before the drug is administered.
Study Details
- Registry ID:
- NCT02436798
- Conditions:
- Adverse Reaction to Other Drugs and Medicines
- Phase:
- Target Enrollment:
- 266 participants
- Start Date:
- Age Range:
- 0.5–45 years
- Healthy Volunteers:
- No
Study Locations (1 site)
-
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
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