NCT00518102

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,431

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

2.3 years

First QC Date

August 16, 2007

Last Update Submit

July 15, 2016

Conditions

Diabetes Mellitus

Keywords

REGRANEX (becaplermin)Platelet-derived growth factor BBCancerCancer incidenceCancer mortality

Outcome Measures

Primary Outcomes (1)

  • 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).

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

Secondary Outcomes (1)

  • The number of reported deaths from cancer in patients who have used REGRANEX (becaplermin) and patients who have not used not used REGRANEX (becaplermin).

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

Study Arms (2)

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)

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

Interventions

REGRANEX (becaplermin)DRUG

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).

001
REGRANEX (becaplermin) comparatorsOTHER

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)

002

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • Any cancer-related diagnoses identified in the claims data during baseline (the 6 month period prior to REGRANEX (becaplermin) initiation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Diabetes MellitusNeoplasms

Interventions

Becaplermin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Proto-Oncogene Proteins c-sisPlatelet-Derived Growth FactorIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsDNA-Binding ProteinsProteinsBiological Factors

Study Officials

  • Ethicon, Inc. Clinical Trial

    Ethicon, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 20, 2007

Study Start

January 1, 2003

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

July 19, 2016

Record last verified: 2016-07