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

NCT ID: NCT00925457

Last Updated: 2016-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1608 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-03-31

Brief Summary

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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

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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

Conditions

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Arrhythmias, Cardiac

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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001

Current Domperidone Current domperidone at any dose regardless of proton pump inhibitor status

Current Domperidone

Intervention Type DRUG

Current domperidone at any dose, regardless of proton pump inhibitor status

002

Current proton pump inhibitor (PPI) Current PPI and not current dapoxetine

Current proton pump inhibitor (PPI)

Intervention Type DRUG

Current PPI and not current dapoxetine

003

No Intervention Neither current domperidone nor current PPI

No Intervention

Intervention Type OTHER

Neither current domperidone nor current PPI

Interventions

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No Intervention

Neither current domperidone nor current PPI

Intervention Type OTHER

Current Domperidone

Current domperidone at any dose, regardless of proton pump inhibitor status

Intervention Type DRUG

Current proton pump inhibitor (PPI)

Current PPI and not current dapoxetine

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=811&filename=CR016396_Executive_Summary.pdf

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

Other Identifiers

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CR016396

Identifier Type: -

Identifier Source: org_study_id

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