NCT02436798|Completed
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Sponsor study identifier
observational
266
1 country
1
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2020
Actual (reported)Study Completion
August 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
April 1, 2015
Actual (reported)May 7, 2015
Actual (reported)August 2020
Actual (reported)August 2020
Actual (reported)Identify clinical and genetic variants associated with ondansetron-induced prolongation of QT interval
Up to 2 years
Children \<6 months to 18 years of age receiving ondansetron for management of: 1. Post-operative nausea and vomiting 2. Chemotherapy-induced nausea and vomiting
Pregnant patients or women of a reproductive age (18-45 years) receiving ondansetron for management of: 1. Hyperemesis gravidarum 2. Post-operative nausea and vomiting
All patients will be receiving treatment with ondansetron as part of standard care.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Children, women of a reproductive age, and pregnant women receiving ondansetron for treatment of post-operative or chemotherapy-induced nausea and vomiting or hyperemesis gravidarum.
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3V4, Canada
DNA samples will be retained for genomic analyses.
Bruce Carleton, PharmD.
University of British Columbia
266 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2015
First Posted
May 7, 2015
Study Start
June 2014
Date type not reportedThis date has not been verified as actual or estimated.
Heart Safety Study of Ondansetron in Children Receiving Chemotherapy
Contact the study team to confirm eligibility.
Primary Completion
August 2020
Actual (reported)Study Completion
August 2020
Actual (reported)Last Updated
May 14, 2021
Record last verified: 2021-05
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Source: ClinicalTrials.gov.
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