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

July 15, 2016 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 99 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
From time of recruitment beginning in October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.
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.
From time of accrual beginning in October 1, 1999 until the earliest of September 30, 2007 or death.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
From the date of the first becaplermin dispensing beginning October 1, 1999 until the earliest of September 30, 2007, outcome identification, or death.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborators

Bedford Research Corporation, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

November 4, 2010

First Submitted That Met QC Criteria

November 4, 2010

First Posted (ESTIMATE)

November 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 15, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR017497
  • REGRANEX-EPI-02 (OTHER: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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