Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 18, 2009
March 15, 2012
Not Provided
December 2005   (final data collection date for primary outcome measure)
The occurance of serious ventricular arrhythmia and sudden cardiac death (combined end point) [ Time Frame: Retrospective study ] [ Designated as safety issue: Yes ]
The occurrence of serious ventricular arrhythmia and sudden cardiac death (combined end point) [ Time Frame: Retrospective study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00925457 on ClinicalTrials.gov Archive Site
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 ]
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 study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone
Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone

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.

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

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

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

Arrhythmias, Cardiac
  • Other: No Intervention
    Neither current domperidone nor current PPI
  • Drug: Current Domperidone
    Current domperidone at any dose, regardless of proton pump inhibitor status
  • Drug: Current proton pump inhibitor (PPI)
    Current PPI and not current dapoxetine
  • 001
    Current Domperidone Current domperidone at any dose regardless of proton pump inhibitor status
    Intervention: Drug: Current Domperidone
  • 002
    Current proton pump inhibitor (PPI) Current PPI and not current dapoxetine
    Intervention: Drug: Current proton pump inhibitor (PPI)
  • 003
    No Intervention Neither current domperidone nor current PPI
    Intervention: Other: No Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1608
December 2005
December 2005   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00925457
CR016396
Not Provided
Senior Director, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP