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

July 15, 2016 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1608

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
Current Domperidone Current domperidone at any dose regardless of proton pump inhibitor status
Drug: Current Domperidone
Current domperidone at any dose, regardless of proton pump inhibitor status
002
Current proton pump inhibitor (PPI) Current PPI and not current dapoxetine
Drug: Current proton pump inhibitor (PPI)
Current PPI and not current dapoxetine
003
No Intervention Neither current domperidone nor current PPI
Other: No Intervention
Neither current domperidone nor current PPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The occurrence of serious ventricular arrhythmia and sudden cardiac death (combined end point)
Time Frame: Retrospective study
Retrospective study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Retrospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

June 18, 2009

First Submitted That Met QC Criteria

June 19, 2009

First Posted (Estimate)

June 22, 2009

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR016396

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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