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Post-Authorization Safety Study: Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Users of Proton Pump Inhibitors, and Users of Metoclopramide
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.
Details
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Status | COMPLETED |
| Enrolment | 15000 |
| Start date | 2011-12 |
| Completion | 2013-12 |
Conditions
- Death, Sudden, Cardiac
Interventions
- No intervention
Primary outcomes
- Number of out-of-hospital sudden cardiac death (SCD) associated with the exposure to domperidone, proton pump inhibitor, metoclopramide, and none of these medications — 7 years
This will be evaluated for the number of study participants (who had SCD) exposed to domperidone, proton pump inhibitor, metoclopramide, and none of these medications. SCD is defined as a natural death from an unexpected circulatory arrest, usually due to a cardiac arrhythmia (irregular heartbeat). - Number of out-of-hospital Sudden Cardiac Death (SCD) in relation to domperidone exposure period and domperidone non-exposure period — 7 years
This will be evaluated for the number of study participants who had SCD in relation to domperidone exposure period and domperidone non-exposure period. SCD is defined as a natural death from an unexpected circulatory arrest, usually due to a cardiac arrhythmia (irregular heartbeat). This will be analyzed by case-crossover method (self-matching design) which will be adjusted for personal characteristics that vary little over time in each individual. eg, for obesity. - Number of out-of-hospital Sudden Cardiac Deaths (SCD) in relation to Proton Pump Inhibitor (PPI) exposure period and PPI non-exposure period — 7 years
This will be evaluated for the number of study participants who had SCD in relation to PPI exposure period and PPI non-exposure period. SCD is defined as a natural death from an unexpected circulatory arrest, usually due to a cardiac arrhythmia (irregular heartbeat). This will be analyzed by case-crossover method (self-matching design) which will be adjusted for personal characteristics that vary little over time in each individual. eg, for obesity. - Number of out-of-hospital Sudden Cardiac Deaths (SCD) in relation to metoclopramide exposure period and metoclopramide non-exposure period — 7 years
This will be evaluated for the number of study participants who had SCD in relation to metoclopramide exposure period and metoclopramide non-exposure period. SCD is defined as a natural death from an unexpected circulatory arrest, usually due to a cardiac arrhythmia (irregular heartbeat). This will be analyzed by case-crossover method (self-matching design) which will be adjusted for personal characteristics that vary little over time in each individual. eg, for obesity.