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

NCT01907633 | Completed

• 3 other identifiers: CR102051RRA-7880Epi 316
• Study Type: observational
• Target: 15,000
• Locations: 0 countries
• Sites: N/A

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 Inhibitor (PPI), current use of metoclopramide, or non-use of any of these medications.

Conditions

Death, Sudden, Cardiac

Keywords

Death, Sudden, Cardiac; Risk of Sudden Cardiac Death; Domperidone; Proton Pump Inhibitors (PPI); Metoclopramide; Observational Study

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Domperidone/ a proton pump inhibitor/metoclopramide users

Study patients had at least one prescription for domperidone, a proton pump inhibitor, or metoclopramide. Proton pump inhibitors observed in this study are: omeprazole, lansoprazole, esomeprazole, rabeprazole, and pantoprazole.

Drug: No intervention

Interventions

No intervention DRUG

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.

Also known as: Motilium

Domperidone/ a proton pump inhibitor/metoclopramide users

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with exposure to domperidone, proton pump inhibitor, and metoclopramide

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

MeSH Terms

Conditions

Death, Sudden, Cardiac

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 25, 2013
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 19, 2015

Record last verified: 2015-05