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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