A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00528931
First received: September 11, 2007
Last updated: July 11, 2012
Last verified: July 2012
Results First Received: September 24, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Dupuytren's Contracture
Intervention: Biological: collagenase clostridium histolyticum

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
AA4500 0.58 mg collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint

Participant Flow:   Overall Study
    AA4500 0.58 mg  
STARTED     16  
COMPLETED     15  
NOT COMPLETED     1  
Lost to Follow-up                 1  



  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.
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Reporting Groups
  Description
AA4500 0.58 mg collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint

Baseline Measures
    AA4500 0.58 mg  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     4  
Age  
[units: years]
Mean ± Standard Deviation
  60.6  ± 11.74  
Gender  
[units: participants]
 
Female     1  
Male     15  
Race/Ethnicity, Customized  
[units: participants]
 
Black or African American     1  
White     14  
Other     1  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures

1.  Primary:   Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500   [ Time Frame: Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30 ]

2.  Secondary:   Clinical Success   [ Time Frame: 30 days after treatment to the primary joint ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Clinical Improvement   [ Time Frame: 30 days after first treatment to the primary joint ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Percent Reduction From Baseline Contracture   [ Time Frame: 30 days after first treatment to the primary joint ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change From Baseline Range of Motion   [ Time Frame: 30 days after first treatment to the primary joint ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Time to First Achieve and Maintain Clinical Success   [ 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 posted.   Anticipated Posting 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


Responsible Party: Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00528931     History of Changes
Other Study ID Numbers: AUX-CC-855
Study First Received: September 11, 2007
Results First Received: September 24, 2010
Last Updated: July 11, 2012
Health Authority: United States: Food and Drug Administration