Becaplermin Use and Cancer Risk in a Patient Population of U.S. Veterans With Diabetes
A Study of Cancer Risk Associated With Becaplermin Use in Veteran Diabetes Patients Served by the U.S. Veterans Health Administration
2 other identifiers
observational
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2010
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 4, 2010
CompletedFirst Posted
Study publicly available on registry
November 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJuly 19, 2016
July 1, 2016
1 year
November 4, 2010
July 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Secondary Outcomes (1)
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.
Study Arms (2)
001
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)
Interventions
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)
A cohort of becaplermin users (ie, patients with diabetes treated with becaplermin)
Eligibility Criteria
Patients with diabetic foot ulcers who are members of the U.S. Department of Veterans Affairs Health Care System (VA)
You may qualify if:
- Patients with diabetic foot ulcers who are members of the U.S Department of Veterans Affairs Health Care System (VA)
You may not qualify if:
- History of cancer (including nonmelanoma skin cancer) prior to study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2010
First Posted
November 5, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
July 19, 2016
Record last verified: 2016-07