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NCT00925457 Clinical Trial

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

Arrhythmias, Cardiac Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00925457
Other study ID # CR016396
Secondary ID
Status Completed
Phase N/A
First received June 18, 2009
Last updated July 15, 2016
Start date March 2007
Est. completion date March 2009

Study information
Verified date July 2016
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 1608
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group N/A to 99 Years
Eligibility 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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Outcome
Type Measure Description Time frame Safety issue
Primary The occurrence of serious ventricular arrhythmia and sudden cardiac death (combined end point) Retrospective study Yes
Secondary 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 Yes
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