Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518102
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2007-08-16
Brief Title:
The Risk of Cancer in Users of Regranex Becaplermin and Matched Comparators Nonusers of Regranex Becaplermin
Sponsor:
Ethicon Inc
Organization:
Ethicon Inc
Study Overview
Official Title:
A Matched Cohort Study of Regranex Becaplermin and the Risk of Cancer
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 study is to compare the risk of cancers in patients who have used REGRANEX becaplermin to that of patients with similar characteristics and health issues who have not used REGRANEX becaplermin REGRANEX becaplermin is topical medication used to treat non-healing neuropathic foot ulcers in patients with diabetes
Detailed Description:
This is an observational retrospective study where data will be collected from a medical claims database derived from a large national managed care organization with over five million members Members enrolled in a Medicare supplement program will also be included The objective of this study is to determine the incidence of cancer among patients who have used REGRANEX becaplermin compared to patients who have not used REGRANEX becaplermin REGRANEX becaplermin is an FDA-approved prescription medicine that contains a platelet-derived growth factor that is used for the treatment of foot ulcers in patients with diabetes Patients who were treated with REGRANEX becaplermin between January 1998 and June 2003 will be identified in a health insurance claims database Another group of patients who have not been treated with REGRANEX becaplermin but have similar characteristics to patients treated with REGRANEX becaplermin will also be identified during the same time frame in the database Medical record abstraction and review will be conducted to verify all incident cancers identified Follow-up for study outcomes will be conducted from the date of accrual through termination of health-plan membership or December 2003 whichever comes first The date of accrual is the date of REGRANEX becaplermin exposure for each exposed patient and his or her matched unexposed comparison patients Any incidence of death from cancer will also be identified The primary outcome measure in the study will be the incidence rate of cancers of all kinds grouped by organ site in patients who have used REGRANEX becaplermin and patients who have not used REGRANEX becaplermin A secondary objective is a similar comparison of the incidence of death from cancer This is an observational study no investigational drug will be administered
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 |
|---|---|---|---|
| REGRANEX-EPI-01 | OTHER | Ethicon Inc | None |