DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017