Diabetes MellitusNCT00518102
The Risk of Cancer in Users of Regranex (Becaplermin) and Matched Comparators (Nonusers of Regranex [Becaplermin])
An observational study of Diabetes Mellitus, run by Ethicon, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- REGRANEX (becaplermin) and REGRANEX (becaplermin) comparators
- How many people
- 4,431 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to May 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Must have at least 6 months of continuous enrollment in health plan prior to Regranex initiation
Who cannot join
- Any cancer-related diagnoses identified in the claims data during baseline (the 6 month period prior to REGRANEX (becaplermin) initiation).
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- REGRANEX (becaplermin), REGRANEX (becaplermin) comparators
- Keywords
- REGRANEX (becaplermin), Platelet-derived growth factor BB, Cancer, Cancer incidence, Cancer mortality
- Medical subject headings
- Diabetes Mellitus, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) Receives: Other: REGRANEX (becaplermin) comparators |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: From the date of accrual until the earliest of December 2003, outcome identification, health plan disenrollment, or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startJan 2003
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ethicon, Inc. Clinical Trial, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518102
- Sponsor's protocol ID
- CR012010
- Other IDs
- REGRANEX-EPI-01
- Status last verified
- Jul 2016
- First submitted
- 16 Aug 2007
- Last updated
- 19 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Matched Cohort Study of Regranex (Becaplermin) and the Risk of Cancer
- ClinicalTrials.gov ID
- NCT00518102
- Acronym / sponsor ID
- CR012010
- Conditions
- Diabetes Mellitus
- Keywords
- REGRANEX (becaplermin), Platelet-derived growth factor BB, Cancer, Cancer incidence, Cancer mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,431 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 20 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: REGRANEX (becaplermin)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 | – | Other: REGRANEX (becaplermin) comparatorsREGRANEX (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) |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Must have at least 6 months of continuous enrollment in health plan prior to Regranex initiation
Key exclusion criteria (1 listed)
- Any cancer-related diagnoses identified in the claims data during baseline (the 6 month period prior to REGRANEX (becaplermin) initiation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 001 |
| REGRANEX (becaplermin) comparatorsA 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 | 002 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- The Risk of Cancer in Users of REGRANEX (becaplermin) and Matched Comparators (Nonusers of REGRANEX \[becaplermin\])Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethicon, Inc. Clinical Trial study director
Ethicon, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Ethicon, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.