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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00925457
First received: June 18, 2009
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Arrhythmias, Cardiac
Other: No Intervention
Drug: Current Domperidone
Drug: Current proton pump inhibitor (PPI)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The occurance of serious ventricular arrhythmia and sudden cardiac death (combined end point) [ Time Frame: Retrospective study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1608
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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 occurance 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925457

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

Responsible Party: Senior Director, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00925457     History of Changes
Other Study ID Numbers: CR016396
Study First Received: June 18, 2009
Last Updated: March 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Serious ventricular arrhythmia
Sudden cardiac death
Domperidone
Case-control study
Saskatchewan residents
Observational Study

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Death, Sudden, Cardiac
Death
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden
Domperidone
Proton Pump Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014