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

July 15, 2016 updated by: Ethicon, Inc.

A Matched Cohort Study of Regranex (Becaplermin) and the Risk of Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

4431

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

20 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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).

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From the date of accrual until the earliest of December 2003, outcome identification, health plan disenrollment, or death

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From the date of accrual until the earliest of December 2003, outcome identification, health plan disenrollment, or death

Collaborators and Investigators

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

Sponsor

Ethicon, Inc.

Investigators

  • Study Director: Ethicon, Inc. Clinical Trial, Ethicon, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2003

Primary Completion (Actual)

May 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

August 16, 2007

First Submitted That Met QC Criteria

August 16, 2007

First Posted (Estimate)

August 20, 2007

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

  • CR012010
  • REGRANEX-EPI-01 (Other Identifier: Ethicon, Inc.)

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.

Clinical Trials on Diabetes Mellitus

Clinical Trials on REGRANEX (becaplermin)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe