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

Diabetes Mellitus Clinical Trial

Official title:

A Study of Cancer Risk Associated With Becaplermin Use in Veteran Diabetes Patients Served by the U.S. Veterans Health Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235260
• Other study ID #: CR017497
• Secondary ID: REGRANEX-EPI-02
• Status: Completed
• Phase: N/A
• First received: November 4, 2010
• Last updated: July 15, 2016
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: July 2016
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 99 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot
• Diabetic Neuropathies
• Foot Ulcer

Intervention

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)

Drug:
• Becaplermin users
A cohort of becaplermin users (ie, patients with diabetes treated with becaplermin)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Bedford Research Corporation, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		From time of recruitment beginning in October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.	Yes
Primary	The number and rate of deaths from cancer in patients who have used becaplermin and patients who have not used not used becaplermin.		From time of accrual beginning in October 1, 1999 until the earliest of September 30, 2007 or death.	Yes
Secondary	The number of becaplermin doses associated with risk of incident cancer and/or cancer death.		From the date of the first becaplermin dispensing beginning October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.	Yes