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

Death, Sudden, Cardiac Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907633
• Other study ID #: CR102051
• Secondary ID: RRA-7880Epi 316
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2013
• Last updated: May 18, 2015
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Observational

Clinical Trial 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.

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 outcome [cases] and comparison patients without that outcome [controls] are observed to assess their exposure to the medication being studied [domperidone, PPI's and metoclopramide]). The data will come from the United Kingdom's Clinical Practice Research Datalink. The study will estimate the rate of SCD during periods of exposure to each of the study medications, and during periods of exposure to none of them; and the ratios of these rates. It will also use a "case-crossover" analysis (in which each case serves as his/her own control) to re-estimate these rate ratios in a manner that takes account of personal characteristics such as obesity or smoking that may affect the study findings and are incompletely recorded in the database.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15000
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Death
• Death, Sudden
• Death, Sudden, Cardiac

Intervention

Drug:
• No intervention
This is an observational and a retrospective study of existing data, so there will be no interventions. The exposure groups will be domperidone, proton pump inhibitors (omeprazole, lansoprazole, esomeprazole, rabeprazole, and pantoprazole), and metoclopramide.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of out-of-hospital sudden cardiac death (SCD) associated with the exposure to domperidone, proton pump inhibitor, metoclopramide, and none of these medications	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).	7 years	Yes
Primary	Number of out-of-hospital Sudden Cardiac Death (SCD) in relation to domperidone exposure period and domperidone non-exposure period	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.	7 years	Yes
Primary	Number of out-of-hospital Sudden Cardiac Deaths (SCD) in relation to Proton Pump Inhibitor (PPI) exposure period and PPI non-exposure period	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.	7 years	Yes
Primary	Number of out-of-hospital Sudden Cardiac Deaths (SCD) in relation to metoclopramide exposure period and metoclopramide non-exposure period	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.	7 years	Yes