Overview
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
Status:
Completed
Completed
Trial end date:
2013-12-01
2013-12-01
Target enrollment:
0
0
Participant gender:
All
All
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 Inhibitor (PPI), current use of metoclopramide, or non-use of any of these medications.Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Janssen Research & Development, LLCTreatments:
Domperidone
Metoclopramide
Proton Pump Inhibitors
Criteria
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