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| Tracking Information | |||||
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| First Received Date ICMJE | August 16, 2007 | ||||
| Last Updated Date | August 16, 2007 | ||||
| Start Date ICMJE | January 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Risk of Cancer in Users of Regranex (Becaplermin) and Matched Comparators | ||||
| Official Title ICMJE | A Cohort Study of the RIsk of Cancer in Users of Regranex (Becaplermin) and Matched Comparators | ||||
| Brief Summary | The purpose of this retrospective study is to compare the risk of cancers in people who have used becaplermin to that of people with similar characteristics and health issues who have not used becaplermin |
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| Detailed Description | This is an observational (review of records), retrospective (research activity that is performed after the events under the study have occurred) study where data was collected from a medical claims database. The objective of this study was to determine the incidence of cancer among becaplermin users relative to non-users. Adults who were treated with becaplermin between January 1, 2003 and June 30, 2003 were identified in a health insurance claims database. Another group of adults with similar characteristics but who had not been treated with becaplermin were also identified in the database. The medical records of the two groups were followed for an average of 20 months and any diagnosis of cancer was identified and categorized based on type and location of the cancer. Any incidenceof death from cancer was also identified. This retrospective study did not involve the use of any investigational drug and did not mandate the treatment regimen that the patients received. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History, Longitudinal, Defined Population, Retrospective Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 2000 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00518102 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CR012010 | ||||
| Study Sponsor ICMJE | Ethicon, Inc. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Ethicon, Inc. | ||||
| Verification Date | August 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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