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Becaplermin Use and Cancer Risk in a Patient Population of U.S. Veterans With Diabetes

This study has been completed.
Sponsor:
Collaborator:
Bedford Research Corporation, Inc.
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01235260
First received: November 4, 2010
Last updated: July 15, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to evaluate risk of cancer incidence and mortality associated with the use of REGRANEX (becaplermin) in patients with diabetes who are members of a U.S. Veterans Health Administration.

Condition Intervention
Diabetes Mellitus
Foot Ulcer
Diabetic Foot
Diabetic Neuropathies
Other: Becaplermin nonusers
Drug: Becaplermin users

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Study of Cancer Risk Associated With Becaplermin Use in Veteran Diabetes Patients Served by the U.S. Veterans Health Administration

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The number and rate of cases of incident cancers (grouped as non melanoma skin cancer, all other invasive cancers combined, and site specific cancers) in patients who have used becaplermin and patients who have not used becaplermin. [ Time Frame: From time of recruitment beginning in October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death. ] [ Designated as safety issue: Yes ]
  • The number and rate of deaths from cancer in patients who have used becaplermin and patients who have not used not used becaplermin. [ Time Frame: From time of accrual beginning in October 1, 1999 until the earliest of September 30, 2007 or death. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The number of becaplermin doses associated with risk of incident cancer and/or cancer death. [ Time Frame: From the date of the first becaplermin dispensing beginning October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death. ] [ Designated as safety issue: Yes ]

Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001
Becaplermin users A cohort of becaplermin users (ie patients with diabetes treated with becaplermin)
Drug: Becaplermin users
A cohort of becaplermin users (ie, patients with diabetes treated with becaplermin)
002
Becaplermin nonusers A cohort of becaplermin nonusers (ie patients who are not treated with becaplermin but are similar in characteristics to patients in the becaplermin user cohort)
Other: Becaplermin nonusers
A cohort of becaplermin nonusers (ie, patients who are not treated with becaplermin but are similar in characteristics to patients in the becaplermin user cohort)

Detailed Description:
This is an observational study of patients with diabetes who are eligible for care through the national Department of Veterans Affairs Health Care System (VA), representing the largest sample of older adults in an integrated health care system in the U.S. with comprehensive electronic medical records and linkable health survey data. REGRANEX (becaplermin) is topical medication used to treat lower extremity diabetic neuropathic ulcers. VA patients with diabetic foot ulcers who have no prior history of cancer who have received treatment with becaplermin will be compared to a group of similar patients who have not received treatment with becaplermin. Becaplermin users (from the time of initial dispensing of becaplermin) and becaplermin nonusers will be followed forward in time for up to 8 years to identify new cancers and cancer related deaths, with confirmation of cases through registries and medical chart review. This is an observational study; no investigational drug will be administered.
  Eligibility

Ages Eligible for Study:   up to 99 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with diabetic foot ulcers who are members of the U.S. Department of Veterans Affairs Health Care System (VA)
Criteria

Inclusion Criteria:

  • Patients with diabetic foot ulcers who are members of the U.S Department of Veterans Affairs Health Care System (VA)

Exclusion Criteria:

  • History of cancer (including nonmelanoma skin cancer) prior to study entry
  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: NCT01235260

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Bedford Research Corporation, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01235260     History of Changes
Other Study ID Numbers: CR017497  REGRANEX-EPI-02 
Study First Received: November 4, 2010
Last Updated: July 15, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
REGRANEX (becaplermin)
Platelet-derived growth factor BB
Cancer
Cancer incidence
Cancer mortality
Lower Extremity Diabetic Neuropathic Ulcer

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Foot
Foot Ulcer
Diabetic Neuropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Foot Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Platelet-derived growth factor BB
Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 07, 2016