The Risk of Cancer in Users of Regranex (Becaplermin) and Matched Comparators (Nonusers of Regranex [Becaplermin])
NCT00518102 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4431
Last updated 2016-07-19
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.
Conditions
Interventions
- DRUG
-
REGRANEX (becaplermin)
A cohort of REGRANEX (becaplermin) users (ie, patients treated with REGRANEX (becaplermin), a topical medication used to treat non-healing neuropathic foot ulcers in patients with diabetes).
- OTHER
-
REGRANEX (becaplermin) comparators
A cohort of REGRANEX (becaplermin) nonusers (ie, patients who are not treated with REGRANEX \[becaplermin\]) but are similar in characteristics to patients in the REGRANEX \[becaplermin\] user cohort)
Sponsors & Collaborators
-
Ethicon, Inc.
lead INDUSTRY
Principal Investigators
-
Ethicon, Inc. Clinical Trial · Ethicon, Inc.
Eligibility
- Min Age
- 20 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-01-31
- Primary Completion
- 2005-05-31
- Completion
- 2005-05-31
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