Status:
COMPLETED
Retreatment of Recurrent Dupuytren's Contractures
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Dupuytren's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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-spo...
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 contractur...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01498640
Start Date
March 1 2012
End Date
October 1 2013
Last Update
October 5 2017
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
HOPE Research Institute
Phoenix, Arizona, United States, 85050
2
Rockford Orthopedic Associates
Rockford, Illinois, United States, 61107
3
The Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States, 46260
4
Marquette General Health System
Marquette, Michigan, United States, 49855