The Risk of Cancer in Users of Regranex (Becaplermin) and Matched Comparators (Nonusers of Regranex [Becaplermin])

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00518102
First received: August 16, 2007
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Drug: REGRANEX (becaplermin)
Other: REGRANEX (becaplermin) comparators

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Matched Cohort Study of Regranex (Becaplermin) and the Risk of Cancer

Resource links provided by NLM:


Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • The number of reported cases of cancers of all kinds, grouped by organ site in patients who have used REGRANEX (becaplermin) and patients who have not used not used REGRANEX (becaplermin). [ Time Frame: From the date of accrual until the earliest of December 2003, outcome identification, health plan disenrollment, or death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of reported deaths from cancer in patients who have used REGRANEX (becaplermin) and patients who have not used not used REGRANEX (becaplermin). [ Time Frame: From the date of accrual until the earliest of December 2003, outcome identification, health plan disenrollment, or death ] [ Designated as safety issue: No ]

Enrollment: 4431
Study Start Date: January 1998
Groups/Cohorts Assigned Interventions
001
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).
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).
002
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)
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)

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with similar characteristics who were treated or who were not treated with REGRANEX (becaplermin) between January 1998 and June 2003 identified in a health insurance claims database.

Criteria

Inclusion Criteria:

  • Must have at least 6 months of continuous enrollment in health plan prior to Regranex initiation

Exclusion Criteria:

  • Any cancer-related diagnoses identified in the claims data during baseline (the 6 month period prior to REGRANEX (becaplermin) initiation).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518102

Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: Ethicon, Inc. Clinical Trial Ethicon, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00518102     History of Changes
Other Study ID Numbers: CR012010, REGRANEX-EPI-01
Study First Received: August 16, 2007
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ethicon, Inc.:
REGRANEX (becaplermin)
Platelet-derived growth factor BB
Cancer
Cancer incidence
Cancer mortality

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Platelet-derived growth factor BB
Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014