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| Name | Class |
|---|---|
| Auxilium Pharmaceuticals, Inc. | INDUSTRY |
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The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XIAFLEX | Other | XIAFlEX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XIAFLEX | Biological | One Injection of 0.58 mg of Xiaflex into the affected area of the hand. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation. | Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation. | Baseline and 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott W Wolfe, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hosptial for Special Surgery | New York | New York | 10021 | United States |
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Subjects were enrolled from July 2011 to December 2011. Enrollment was completed in a medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | XIAFLEX | 0.58 mg of Xiaflex injected into a palpable Dupuytren's cord |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | XIAFLEX | Patient who have received XIAFLEX |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation. | Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation. | Posted | Mean | Full Range | mm^3 | Baseline and 30 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | XIAFLEX | Patient who received XIAFLEX |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott W. Wolfe | Hospital for Special Surgery | 212-606-1529 | WolfeS@hss.edu |
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| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D003012 | Microbial Collagenase |
| D017364 | Collagenases |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 5 |
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| 5 |
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| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |