Retreatment of Recurrent Dupuytren's Contractures
Completed · Phase 4
Conditions studied: Dupuytren's Disease
In brief
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.
Key facts
- Study ID
- NCT01498640
- Run by
- Endo USA Inc., a Keenova Therapeutics Company
- People needed
- 52
- Starts
- 2012-03-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2017-10-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- HOPE Research Institute — Phoenix, Arizona, United States
- Rockford Orthopedic Associates — Rockford, Illinois, United States
- The Indiana Hand to Shoulder Center — Indianapolis, Indiana, United States
- Marquette General Health System — Marquette, Michigan, United States
- East River Professional Building — New York, New York, United States
- Health Reserarch Institute — Oklahoma City, Oklahoma, United States
- Hand Microsurgery and Reconstructive Orthopaedics — Erie, Pennsylvania, United States
- Peninsula Private Hospital — Kippa-Ring, Queensland, Australia
- AusTrials Sherwood — Sherwood, Queensland, Australia
- Emeritus Research — Malvern East, Victoria, Australia
- Uppsala Akademiska University Hospital — Uppsala, SE, Sweden
- Pulvertaft Hand Center — Derby, GB, United Kingdom
- Newcastle Upon Tyne Hospitals — Newcastle, GB, United Kingdom
Full record on ClinicalTrials.gov
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