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

NCT00925457 | Completed

• 1 other identifier: CR016396
• Study Type: observational
• Target: 1,608
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arrhythmias, Cardiac

Keywords

Serious ventricular arrhythmia; Sudden cardiac death; Domperidone; Case-control study; Saskatchewan residents; Observational Study

Outcome Measures

Primary Outcomes (1)

• The occurrence of serious ventricular arrhythmia and sudden cardiac death (combined end point)

  Retrospective study

Secondary Outcomes (1)

• 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

Study Arms (3)

001

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

Drug: Current Domperidone

002

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

Drug: Current proton pump inhibitor (PPI)

003

No Intervention Neither current domperidone nor current PPI

Other: No Intervention

Interventions

No Intervention OTHER

Neither current domperidone nor current PPI

003

Current Domperidone DRUG

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

001

Current proton pump inhibitor (PPI) DRUG

Current PPI and not current dapoxetine

002

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

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

MeSH Terms

Conditions

Arrhythmias, Cardiac; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2009
• First Posted: June 22, 2009
• Study Start: March 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 19, 2016

Record last verified: 2016-07