Status:

COMPLETED

Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone

Lead Sponsor:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Conditions:

Arrhythmias, Cardiac

Eligibility:

All Genders

Up to 99 years

Brief Summary

The purpose of this retrospective observational study is to obtain information to confirm or contradict the results of prior studies on domperidone and sudden cardiac death. The population studied are...

Detailed Description

The purpose of this population-based, observational study is to evaluate the combined risk of serious ventricular arrhythmia (irregular heart rhythm) and sudden cardiac death in users of domperidone (...

Eligibility Criteria

Inclusion

  • Saskachewan residents who received domperidone or a proton pump inhibitor (PPI) between January 1, 1990, and December 31, 2005

Exclusion

  • Cancer free \>=1 year of history in the database before receiving the first dose of domperidone or a PPI

Key Trial Info

Start Date :

March 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2009

Estimated Enrollment :

1608 Patients enrolled

Trial Details

Trial ID

NCT00925457

Start Date

March 1 2007

End Date

March 1 2009

Last Update

July 19 2016

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