Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone

Official Title: “Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone”

The purpose of this retrospective observational study is to obtain information to confirm or contradict the results of prior studies on domperidone and sudden cardiac death. The population studied are the Saskatchewan residents who used domperidone or another type of medication known as a Proton Pump Inhibitor (PPI) between 1990 and 2005. Information will be collected from various sources including the Saskatchewan Health (SH) database and Cancer Registry.

The purpose of this population-based, observational study is to evaluate the combined risk of serious ventricular arrhythmia (irregular heart rhythm) and sudden cardiac death in users of domperidone (a medication used to treat certain gastrointestinal disorders) compared with users of proton pump inhibitors (another group of medications used to reduce gastric or stomach acid production. The study will be conducted using patient information from Saskatchewan Health (SH) who had recorded dispensings of domperidone or a PPI from 1990 through 2005. The first objective of the study is to estimate the combined relative risk of the occurence of a particular type of irregular heart rhythm known as serious ventricular arrhythmia (SVA) and sudden cardiac death SCD (defined as a natural death from an unexpected circulatory arrest) during current use of domperidone or current use of proton pump inhibitors (PPIs) as compared with nonuse in a diabetic population. The second objective is to estimate the combined relative risk of SVA and SCD during current use of domperidone or current use of PPIs as compared with nonuse in a non-diabetic population.

Study drug dosing information not required for Observational Study

Intervention(s) in this Clinical Trial

• Drug: Current proton pump inhibitor (PPI)
  • Current PPI and not current dapoxetine
• Drug: Current Domperidone
  • Current domperidone at any dose, regardless of proton pump inhibitor status
• Other: No Intervention
  • Neither current domperidone nor current PPI

Arms, Groups and Cohorts in this Clinical Trial

• : 001
• : 002
• : 003

Primary Measures

• The occurence of serious ventricular arrhythmia and sudden cardiac death (combined end point)
  • Time Frame: Retrospective study
    Safety Issue?: Yes

Secondary Measures

• The second objective is to estimate the combined relative risk of SVA and SCD during current use of domperidone or current use of PPIs as compared with nonuse in a non-diabetic population.
  • Time Frame: Retrospective
    Safety Issue?: Yes

Inclusion Criteria:

• Saskatchewan residents who received domperidone or a proton pump inhibitor (PPI) between January 1, 1990, and December 31, 2005

Exclusion Criteria:

• Cancer free >=1 year of history in the database before receiving the first dose of domperidone or a PPI

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Industry

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00925457

Study ID Number: CR016396

ClinicalTrials.gov Identifier: NCT00925457

Health Authority: United States: Institutional Review Board

Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone