MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
This study has been completed.
Sponsor:
Scott Wolfe
Collaborator:
Auxilium Pharmaceuticals, Inc
Information provided by (Responsible Party):
Scott Wolfe, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01450397
First received: October 10, 2011
Last updated: March 18, 2013
Last verified: March 2013
| Tracking Information | |||||
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| First Received Date ICMJE | October 10, 2011 | ||||
| Last Updated Date | March 18, 2013 | ||||
| Start Date ICMJE | March 2011 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary outcome will be the measured volume of the cord by MRI before and after XIAFLEX injection and manual manipulation. [ Time Frame: 30 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01450397 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex | ||||
| Official Title ICMJE | MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex | ||||
| Brief Summary | The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI. |
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| Detailed Description | Collagenase injections for the treatment of Dupuytren's Contracture is a newly approved protocol which has shown early efficacy. There are very few studies which examine the MRI appearance of Dupuytren's disease. There are no studies that evaluate the condition of the cord after collagenase injection. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Dupuytren's Disease | ||||
| Intervention ICMJE | Biological: XIAFLEX
One Injection of 0.58 mg of Xiaflex into the affected area of the hand.
Other Name: Collagenase |
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| Study Arm (s) | XIAFLEX
XIAFlEX
Intervention: Biological: XIAFLEX |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 5 | ||||
| Completion Date | February 2012 | ||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 35 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01450397 | ||||
| Other Study ID Numbers ICMJE | 11052 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Scott Wolfe, Hospital for Special Surgery, New York | ||||
| Study Sponsor ICMJE | Scott Wolfe | ||||
| Collaborators ICMJE | Auxilium Pharmaceuticals, Inc | ||||
| Investigators ICMJE |
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| Information Provided By | Hospital for Special Surgery, New York | ||||
| Verification Date | March 2013 | ||||
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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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