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

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ClinicalTrials.gov Identifier: NCT01450397
Recruitment Status : Completed
First Posted : October 12, 2011
Results First Posted : May 15, 2014
Last Update Posted : April 17, 2017
Sponsor:
Collaborator:
Auxilium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Dupuytren's Disease
Intervention Biological: XIAFLEX
Enrollment 5
Recruitment Details Subjects were enrolled from July 2011 to December 2011. Enrollment was completed in a medical clinic.
Pre-assignment Details  
Arm/Group Title XIAFLEX
Hide Arm/Group Description 0.58 mg of Xiaflex injected into a palpable Dupuytren's cord
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title XIAFLEX
Hide Arm/Group Description Patient who have received XIAFLEX
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  20.0%
>=65 years
4
  80.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
67.6  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
0
   0.0%
Male
5
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.
Hide Description Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.
Time Frame Baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title XIAFLEX
Hide Arm/Group Description:
Subjects receiving one Xiaflex injection
Overall Number of Participants Analyzed 5
Mean (Full Range)
Unit of Measure: mm^3
482
(188 to 670)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection XIAFLEX
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0013
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title XIAFLEX
Hide Arm/Group Description Patient who received XIAFLEX
All-Cause Mortality
XIAFLEX
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
XIAFLEX
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
XIAFLEX
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Scott W. Wolfe
Organization: Hospital for Special Surgery
Phone: 212-606-1529
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01450397     History of Changes
Other Study ID Numbers: 11052
First Submitted: October 10, 2011
First Posted: October 12, 2011
Results First Submitted: October 29, 2013
Results First Posted: May 15, 2014
Last Update Posted: April 17, 2017