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Risk of Cancer in Users of Regranex (Becaplermin) and Matched Comparators
This study is ongoing, but not recruiting participants.
Study NCT00518102   Information provided by Ethicon, Inc.
First Received: August 16, 2007   No Changes Posted

August 16, 2007
August 16, 2007
January 1998
 
 
 
No Changes Posted
 
 
 
Risk of Cancer in Users of Regranex (Becaplermin) and Matched Comparators
A Cohort Study of the RIsk of Cancer in Users of Regranex (Becaplermin) and Matched Comparators

The purpose of this retrospective study is to compare the risk of cancers in people who have used becaplermin to that of people with similar characteristics and health issues who have not used becaplermin

This is an observational (review of records), retrospective (research activity that is performed after the events under the study have occurred) study where data was collected from a medical claims database. The objective of this study was to determine the incidence of cancer among becaplermin users relative to non-users. Adults who were treated with becaplermin between January 1, 2003 and June 30, 2003 were identified in a health insurance claims database. Another group of adults with similar characteristics but who had not been treated with becaplermin were also identified in the database. The medical records of the two groups were followed for an average of 20 months and any diagnosis of cancer was identified and categorized based on type and location of the cancer. Any incidenceof death from cancer was also identified.

This retrospective study did not involve the use of any investigational drug and did not mandate the treatment regimen that the patients received.

Phase IV
Observational
Natural History, Longitudinal, Defined Population, Retrospective Study
  • Cancer
  • Foot Ulcer, Diabetic
  • Diabetic Foot
  • Foot Ulcer
  • Neoplasms
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
2000
 
 

Inclusion Criteria:

  • Patients treated with becaplermin in the medical claims database and subsequently patients similar to them for a matched control group

Exclusion Criteria:

  • Patients not treated with becaplermin
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00518102
 
CR012010
Ethicon, Inc.
 
Study Director: Ethicon, Inc. Clinical Trial Ethicon, Inc.
Ethicon, Inc.
August 2007

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