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

Completed

• Conditions: Arrhythmias, Cardiac
• Interventions: Other: No Intervention; Drug: Current Domperidone; Drug: Current proton pump inhibitor (PPI)

• Registration Number: NCT00925457
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary

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.

Detailed Description

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 occurrence 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

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-06-19
• Study First Posted: 2009-06-22
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-15
• Last Update Posted: 2016-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1608

Inclusion Criteria

• Saskachewan 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
003	No Intervention	No Intervention Neither current domperidone nor current PPI
001	Current Domperidone	Current Domperidone Current domperidone at any dose regardless of proton pump inhibitor status
002	Current proton pump inhibitor (PPI)	Current proton pump inhibitor (PPI) Current PPI and not current dapoxetine

Primary Outcome Measures

Name	Time	Method
The occurrence of serious ventricular arrhythmia and sudden cardiac death (combined end point)	Retrospective study

Secondary Outcome Measures

Name	Time	Method
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.	Retrospective