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Trial record 62 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

5-HT3 Antagonists (Antiemetics) and Cardiac Safety

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ClinicalTrials.gov Identifier: NCT02436798
Recruitment Status : Recruiting
First Posted : May 7, 2015
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Bruce Carleton, University of British Columbia

Tracking Information
First Submitted Date April 1, 2015
First Posted Date May 7, 2015
Last Update Posted Date April 16, 2019
Study Start Date June 2014
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 4, 2015)
Identify clinical and genetic variants associated with ondansetron-induced prolongation of QT interval [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02436798 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 5-HT3 Antagonists (Antiemetics) and Cardiac Safety
Official Title 5-HT3 Antagonists (Antiemetics) and Cardiac Safety Using an Active Surveillance Approach
Brief 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.
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA samples will be retained for genomic analyses.
Sampling Method Probability Sample
Study Population 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.
Condition Adverse Reaction to Other Drugs and Medicines
Intervention Drug: Ondansetron
All patients will be receiving treatment with ondansetron as part of standard care.
Other Name: Zofran
Study Groups/Cohorts
  • Pediatric patients

    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
    Intervention: Drug: Ondansetron
  • Female patients

    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
    Intervention: Drug: Ondansetron
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 4, 2015)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months to 45 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Bruce Carleton, PharmD. bcarleton@popi.ubc.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02436798
Other Study ID Numbers H13-02338
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bruce Carleton, University of British Columbia
Study Sponsor University of British Columbia
Collaborators Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Bruce Carleton, PharmD. University of British Columbia
PRS Account University of British Columbia
Verification Date April 2019