Retreatment of Recurrent Dupuytren's Contractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01498640
First received: December 17, 2011
Last updated: June 12, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
Dupuytren's Disease
Biological: Collagenase clostridium histolyticum
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Clinical Success [ Time Frame: 30 days after last injection ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees


Secondary Outcome Measures:
  • Physician Global Assessment of Improvement [ Time Frame: 30 days after last injection ] [ Designated as safety issue: No ]
    Physician global assessment of change (improvement) in subject's Dupuytren's contracture

  • Subject Global Assessment of Satisfaction [ Time Frame: 30 days after last injection ] [ Designated as safety issue: No ]
    Subject global assessment of overall treatment satisfaction

  • Recurrence of Contracture [ Time Frame: Day 365 ] [ Designated as safety issue: No ]
    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.


Enrollment: 52
Study Start Date: March 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XIAFLEX/XIAPEX MP Joint
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
Biological: Collagenase clostridium histolyticum
up to three 0.58 mg injections
Other Names:
  • XIAFLEX
  • XIAPEX
  • AA4500
Experimental: XIAFLEX/XIAPEX PIP Joint
Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
Biological: Collagenase clostridium histolyticum
up to three 0.58 mg injections
Other Names:
  • XIAFLEX
  • XIAPEX
  • AA4500

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498640

Locations
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
United States, Illinois
Rockford Orthopedic Associates
Rockford, Illinois, United States, 61107
United States, Indiana
The Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States, 46260
United States, Michigan
Marquette General Health System
Marquette, Michigan, United States, 49855
United States, New York
East River Professional Building
New York, New York, United States, 10021
United States, Oklahoma
Health Reserarch Institute
Oklahoma City, Oklahoma, United States, 73109
United States, Pennsylvania
Hand Microsurgery and Reconstructive Orthopaedics
Erie, Pennsylvania, United States, 16507
Australia, Queensland
Peninsula Private Hospital
Kippa Ring, Queensland, Australia, 4021
AusTrials Sherwood
Sherwood, Queensland, Australia, 4075
Australia, Victoria
Emeritus Research
Malvern East, Victoria, Australia, 3145
Sweden
Uppsala Akademiska University Hospital
Uppsala, SE, Sweden, SE-751
United Kingdom
Pulvertaft Hand Center
Derby, GB, United Kingdom, DE22 3NE
Newcastle Upon Tyne Hospitals
Newcastle, GB, United Kingdom, NE1 4LP
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Veronica Urdaneta, MD, MPPH Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01498640     History of Changes
Other Study ID Numbers: AUX-CC-862
Study First Received: December 17, 2011
Results First Received: February 4, 2015
Last Updated: June 12, 2015
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Medical Products Agency

Keywords provided by Endo Pharmaceuticals:
XIAFLEX
XIAPEX
Dupuytren's disease
contracture

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Connective Tissue Diseases
Joint Diseases
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 27, 2015