Ignite Creation Date:
2024-05-05 @ 9:37 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00925457
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2009-06-18
Brief Title:
Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None