5-HT3 Antagonists (Antiemetics) and Cardiac Safety
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Adverse Reaction to Other Drugs and Medicines
Intervention: Ondansetron (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s): Bruce Carleton, PharmD., Principal Investigator, Affiliation: University of British Columbia
Overall contact: Bruce Carleton, PharmD., Email: bcarleton@popi.ubc.ca
Summary
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.
Clinical Details
Official title: 5-HT3 Antagonists (Antiemetics) and Cardiac Safety Using an Active Surveillance Approach
Study design: Time Perspective: Prospective
Primary outcome: Identify clinical and genetic variants associated with ondansetron-induced prolongation of QT interval
Detailed description:
The specific objectives are to:
1. Determine and compare the cardiac safety profile of ondansetron in children, when used
for prevention and management of post-operative nausea and vomiting and chemotherapy
induced nausea and vomiting. Identify clinical factors including pre-existing cardiac
conditions or physiological conditions that predispose to ventricular arrhythmias,
concomitant cardiotoxic chemotherapy or concomitant volatile anaesthetic agents and
investigate their impact on cardiac adverse effects of ondansetron.
2. Determine and compare the cardiac safety profile of ondansetron when used in pregnant
women or women of a reproductive age for the treatment of hyperemesis gravidarum or
post-operative nausea and vomiting. Identify clinical factors including pre-existing
cardiac conditions or physiological conditions, which predispose to ventricular
arrhythmias that may support implementation of risk mitigation actions.
3. Identify genetic variants associated with 5-HT3 antagonist-induced prolongation of QT
interval.
Eligibility
Minimum age: 6 Months.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Children 6 months - 18 years of age who are being treated with ondansetron for
prevention and management of post-operative nausea and vomiting and
chemotherapy-induced nausea and vomiting.
2. Pregnant women and women of a reproductive age (18-45 years of age) who are being
treated with ondansetron for hyperemesis gravidarum or postoperative nausea and
vomiting.
Exclusion Criteria:
1. Patients with congenital long QT syndrome.
2. Subjects who do not speak and understand English.
Locations and Contacts
Bruce Carleton, PharmD., Email: bcarleton@popi.ubc.ca
Children's and Women's Health Centre of British Columbia, Vancouver, British Columbia V6H 3V4, Canada; Recruiting Kaitlyn Shaw, MSc., Phone: 604-875-2000, Ext: 7141, Email: kshaw@popi.ubc.ca Bruce Carleton, PharmD., Principal Investigator
Additional Information
Starting date: June 2014
Last updated: May 4, 2015
|