AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture (CORD-I)

This study has been completed.
Sponsor:
Information provided by:
Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00528606
First received: September 11, 2007
Last updated: January 18, 2012
Last verified: November 2010
Results First Received: September 24, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dupuytren's Contracture
Interventions: Biological: collagenase clostridium histolyticum
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
AA4500 0.58 mg collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Placebo No text entered.

Participant Flow:   Overall Study
    AA4500 0.58 mg     Placebo  
STARTED     204     104  
COMPLETED     191     100  
NOT COMPLETED     13     4  
Withdrew consent                 4                 3  
Lost to Follow-up                 4                 1  
Adverse Event                 3                 0  
Not specified                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AA4500 0.58 mg collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    AA4500 0.58 mg     Placebo     Total  
Number of Participants  
[units: participants]
  204     104     308  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     120     57     177  
>=65 years     84     47     131  
Age  
[units: years]
Mean ± Standard Deviation
  62.3  ± 9.7     63.3  ± 9.1     62.7  ± 9.5  
Gender  
[units: participants]
     
Female     33     30     63  
Male     171     74     245  
Race/Ethnicity, Customized  
[units: participants]
     
White     203     104     307  
Hispanic     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     204     104     308  



  Outcome Measures

1.  Primary:   Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection   [ Time Frame: Within 30 days after the last injection ]

2.  Secondary:   Clinical Improvement After the Last Injection   [ Time Frame: 30 days after last treatment to the primary joint ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Percent Reduction From Baseline Contracture After the Last Injection   [ Time Frame: 30 days after last treatment to the primary joint ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Change From Baseline Range of Motion After the Last Injection   [ Time Frame: 30 days after last treatment to the primary joint ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Time to First Achieve and Maintain Clinical Success After the Last Injection   [ Time Frame: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Clinical Success After the First Injection   [ Time Frame: 30 days after first treatment to the primary joint ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Clinical Improvement After the First Injection   [ Time Frame: 30 days after first treatment to the primary joint ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Percent Reduction From Baseline Contracture After the First Injection   [ Time Frame: 30 days after first treatment to the primary joint ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Change From Baseline Range of Motion After the First Injection   [ Time Frame: 30 days after first treatment to the primary joint ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Greg Kaufman, MD
Organization: Auxilium Pharmaceuticals, Inc.
phone: 484-321-5920 ext 5920
e-mail: gkaufman@auxilium.com


No publications provided by Auxilium Pharmaceuticals

Publications automatically indexed to this study:

Responsible Party: John Rodzvilla/ Vice President, Medical Development, Auxilium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00528606     History of Changes
Other Study ID Numbers: AUX-CC-857
Study First Received: September 11, 2007
Results First Received: September 24, 2010
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration