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Domperidone and Risk of Sudden Cardiac Death

NCT02500108 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 214962

Last updated 2024-02-09

No results posted yet for this study

Summary

The purpose of this study is to assess the risk of serious cardiac events, specifically ventricular tachyarrhythmia and sudden cardiac death (VT/SCD), associated with the use of domperidone in a population of patients with Parkinson's disease. The hypothesis for this study is that the risk of VT/SCD will be higher among domperidone users, especially at a higher dose.

The investigators will conduct a retrospective population-based cohort study using health care databases in eight jurisdictions in Canada and the UK. The study cohort will be defined by the initiation of a new antiparkinsonian drug or a new diagnosis of Parkinson's disease. The results from the separate sites will be combined by meta-analysis to provide an overall assessment of the risk of VT/SCD in users of domperidone.

Conditions

Interventions

DRUG

Domperidone

Current exposure to domperidone will be defined as a prescription dispensed within 30 days before the index date. Recent exposure to domperidone will be defined as a prescription dispensed between 31 and 90 days before the index date (without a dispensing during the 30 days period preceding index date). Past exposure to domperidone will be defined as a prescription dispensed between 91 and 365 days before the index date (without prescription in the 90 days period prior index date).

Sponsors & Collaborators

  • Drug Safety and Effectiveness Network, Canada

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Canadian Network for Observational Drug Effect Studies, CNODES

    lead OTHER

Principal Investigators

  • Christel Renoux, MD, PhD · Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02500108 on ClinicalTrials.gov