Retreatment of Recurrent Dupuytren's Contractures
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
1 other identifier
interventional
52
4 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2012
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2011
CompletedFirst Posted
Study publicly available on registry
December 23, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
February 20, 2015
CompletedOctober 5, 2017
September 1, 2017
1.6 years
December 17, 2011
February 4, 2015
September 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Clinical Success
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
30 days after last injection
Percent Change From Baseline in Degree of Contracture
Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees
Baseline and 30 days after last injection
Change in Range of Motion
Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees
Baseline and 30 days after last injection
Secondary Outcomes (3)
Physician Global Assessment of Improvement
30 days after last injection
Subject Global Assessment of Satisfaction
30 days after last injection
Recurrence of Contracture
Day 365
Study Arms (2)
XIAFLEX/XIAPEX MP Joint
EXPERIMENTALUp to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
XIAFLEX/XIAPEX PIP Joint
EXPERIMENTALUp to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
Interventions
up to three 0.58 mg injections
Eligibility Criteria
You may qualify if:
- Provide written informed consent
- Be currently participating in the AUX-CC-860 follow-up study
- 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
- Be able to comply with the study visit schedule as specified in the protocol
You may not qualify if:
- Is a pregnant or lactating female or female intending to become pregnant during the study
- Has hypersensitivity to AA4500 or any of the AA4500 excipients
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Rockford Orthopedic Associates
Rockford, Illinois, 61107, United States
The Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260, United States
Marquette General Health System
Marquette, Michigan, 49855, United States
East River Professional Building
New York, New York, 10021, United States
Health Reserarch Institute
Oklahoma City, Oklahoma, 73109, United States
Hand Microsurgery and Reconstructive Orthopaedics
Erie, Pennsylvania, 16507, United States
Peninsula Private Hospital
Kippa-Ring, Queensland, 4021, Australia
AusTrials Sherwood
Sherwood, Queensland, 4075, Australia
Emeritus Research
Malvern East, Victoria, 3145, Australia
Uppsala Akademiska University Hospital
Uppsala, SE, SE-751, Sweden
Pulvertaft Hand Center
Derby, GB, DE22 3NE, United Kingdom
Newcastle Upon Tyne Hospitals
Newcastle, GB, NE1 4LP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Coordinator
- Organization
- Endo Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Veronica Urdaneta, MD, MPPH
Endo Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2011
First Posted
December 23, 2011
Study Start
March 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
October 5, 2017
Results First Posted
February 20, 2015
Record last verified: 2017-09