Status:

COMPLETED

An Observational Study to Assess the Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Users of Proton Pump Inhibitors, and Users of Metoclopramide

Lead Sponsor:

Janssen Research & Development, LLC

Conditions:

Death, Sudden, Cardiac

Eligibility:

All Genders

2+ years

Brief Summary

The purpose of this observational study is to assess the risk of out-of-hospital Sudden Cardiac (heart) Death (SCD) associated with current use of domperidone compared to current use of a Proton Pump ...

Detailed Description

This is a population-based, retrospective (a study in which the exposures and outcomes occurred before the study began), and nested case-control study (a study in which the patients with the study out...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • \- Patients registered in English practices whose data are linkable to Hospital Episode Statistics (HES) and Office for National Statistics, UK (ONS). Patients are required to have at least 1 year in the Clinical Practice Research Datalink before they can enter the study
  • Exclusion criteria:
  • Patients with a diagnosis of cancer other than non-melanoma skin cancer
  • Patients from practices not linkable to HES and ONS data
  • Patient time corresponding to the period between hospital admission date and 30 days after discharge date

Exclusion

    Key Trial Info

    Start Date :

    December 1 2011

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2013

    Estimated Enrollment :

    15000 Patients enrolled

    Trial Details

    Trial ID

    NCT01907633

    Start Date

    December 1 2011

    End Date

    December 1 2013

    Last Update

    May 19 2015

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