MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex

This study has been completed.
Sponsor:
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

October 10, 2011
March 18, 2013
March 2011
January 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01450397 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dupuytren's Disease
Biological: XIAFLEX
One Injection of 0.58 mg of Xiaflex into the affected area of the hand.
Other Name: Collagenase
XIAFLEX
XIAFlEX
Intervention: Biological: XIAFLEX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
February 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has a diagnosis of Dupuytren's Disease affecting only the metacarpophalangeal joint of the 4th or 5th finger.
  • Subject has only one finger affected by the disease.
  • Patients will be 35 years of age of older.
  • Patients will be able to read, speak, and understand English or have available adequate translation assistance and be able to provide voluntary written consent to participate.

Exclusion Criteria:

  • Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase.
  • Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands.
  • Patient has known allergy to collagenase or any other excipient of Xiaflex.
  • Patient has received any collagenase treatments before the first dose of Xiaflex.
  • Patient with abnormal coagulation, including patients who have received anticoagulant medications other than low-dose aspirin within 7 days of the injection.
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01450397
11052
No
Scott Wolfe, Hospital for Special Surgery, New York
Scott Wolfe
Auxilium Pharmaceuticals, Inc
Principal Investigator: Scott W Wolfe, MD Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP