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Retreatment of Recurrent Dupuytren's Contractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01498640
Recruitment Status : Completed
First Posted : December 23, 2011
Results First Posted : February 20, 2015
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE December 17, 2011
First Posted Date  ICMJE December 23, 2011
Results First Submitted Date  ICMJE February 4, 2015
Results First Posted Date  ICMJE February 20, 2015
Last Update Posted Date October 5, 2017
Study Start Date  ICMJE March 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
  • Clinical Success [ Time Frame: 30 days after last injection ]
    Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500
  • Percent Change From Baseline in Degree of Contracture [ Time Frame: Baseline and 30 days after last injection ]
    Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees
  • Change in Range of Motion [ Time Frame: Baseline and 30 days after last injection ]
    Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2011)
The change in degree of flexion from baseline [ Time Frame: 30 days after the last injection of AA4500 ]
Change History Complete list of historical versions of study NCT01498640 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
  • Physician Global Assessment of Improvement [ Time Frame: 30 days after last injection ]
    Physician global assessment of change (improvement) in subject's Dupuytren's contracture
  • Subject Global Assessment of Satisfaction [ Time Frame: 30 days after last injection ]
    Subject global assessment of overall treatment satisfaction
  • Recurrence of Contracture [ Time Frame: Day 365 ]
    Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Retreatment of Recurrent Dupuytren's Contractures
Official Title  ICMJE Retreatment of Recurrent Contractures in Joints Effectively Treated With AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States, Australia, and Europe
Brief Summary The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.
Detailed Description

Open-label, Phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, AUX-CC-860) in the United States, Australia, or Europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the Day 30 value after the last injection in a Phase 3 Auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with AA4500 in a Phase 3 Auxilium-sponsored study.

Subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. The investigator will treat the cord affecting the recurrent joint with up to three injections. Only one recurrent joint will be treated in this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dupuytren's Disease
Intervention  ICMJE Biological: Collagenase clostridium histolyticum
up to three 0.58 mg injections
Other Names:
  • XIAFLEX
  • XIAPEX
  • AA4500
Study Arms  ICMJE
  • Experimental: XIAFLEX/XIAPEX MP Joint
    Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
    Intervention: Biological: Collagenase clostridium histolyticum
  • Experimental: XIAFLEX/XIAPEX PIP Joint
    Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
    Intervention: Biological: Collagenase clostridium histolyticum
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2014)
52
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2011)
100
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Provide written informed consent
  2. Be currently participating in the AUX-CC-860 follow-up study
  3. Have at least one joint with all of the following:

    • The joint was effectively treated (had a correction to 5 degrees or less at the Day 30 evaluation after the last injection of AA4500) in a previous Auxilium Phase 3 study
    • The effectively treated joint has an increase in contracture of at least 20 degrees compared with the Day 30 value after the last injection of AA4500 in a previous Auxilium Phase 3 study
    • A palpable cord is present in the joint to be treated
  4. Be able to comply with the study visit schedule as specified in the protocol

Exclusion Criteria:

  1. Is a pregnant or lactating female or female intending to become pregnant during the study
  2. Has hypersensitivity to AA4500 or any of the AA4500 excipients
  3. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for equal to or less than 150 mg aspirin daily and over-the-counter nonsteroidal antiinflammatory drugs [NSAIDs]) within 7 days before injection of AA4500
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01498640
Other Study ID Numbers  ICMJE AUX-CC-862
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Endo Pharmaceuticals
Study Sponsor  ICMJE Endo Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Veronica Urdaneta, MD, MPPH Endo Pharmaceuticals
PRS Account Endo Pharmaceuticals
Verification Date September 2017

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