Ignite Creation Date:
2024-05-06 @ 1:48 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01907633
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2013-07-22
Brief Title:
An Observational Study to Assess the Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone Users of Proton Pump Inhibitors and Users of Metoclopramide
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
Post-Authorization Safety Study Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone Users of Proton Pump Inhibitors and Users of Metoclopramide
Status:
COMPLETED
Status Verified Date:
2015-05
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 observational study is to assess the risk of out-of-hospital Sudden Cardiac heart Death SCD associated with current use of domperidone compared to current use of a Proton Pump Inhibitor PPI current use of metoclopramide or non-use of any of these medications
Detailed Description:
This is a population-based retrospective a study in which the exposures and outcomes occurred before the study began and nested case-control study a study in which the patients with the study outcome cases and comparison patients without that outcome controls are observed to assess their exposure to the medication being studied domperidone PPIs and metoclopramide The data will come from the United Kingdoms Clinical Practice Research Datalink The study will estimate the rate of SCD during periods of exposure to each of the study medications and during periods of exposure to none of them and the ratios of these rates It will also use a case-crossover analysis in which each case serves as hisher own control to re-estimate these rate ratios in a manner that takes account of personal characteristics such as obesity or smoking that may affect the study findings and are incompletely recorded in the database
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Epi 316 | OTHER | Janssen Research Development LLC | None |
| RRA-7880 | OTHER | None | None |