Status:
COMPLETED
Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Dupuytren's Disease
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of study AUX-CC-860 is to assess the durability of response of the AA4500 treatment regimen. This study will also evaluate long-term safety and progression of disease in joints.
Detailed Description
Phase 3 non-treatment study in which Year 2 to Year 5 year follow-up of subjects who received AA4500 in the 9-month open-label studies (AUX-CC-854 and AUX-CC-856) or the 12-month double-blind with ope...
Eligibility Criteria
Inclusion
- To be eligible for this study a subject had to:
- Have received at least one injection of AA4500 in one of the Auxilium sponsored studies (AUX-CC-854, AUX-CC-856, Studies AUX-CC-857/AUX-CC-858, or AUX-CC-859) and have at least one fixed-flexion contracture measurement after treatment with AA4500
- Be able and willing to comply with the yearly assessments outlined in the protocol, as determined by the investigator
- Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC)
Exclusion
- None
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
645 Patients enrolled
Trial Details
Trial ID
NCT00954746
Start Date
July 1 2009
End Date
May 1 2013
Last Update
June 16 2015
Active Locations (39)
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1
Hope Research Institute
Phoenix, Arizona, United States, 85050
2
Tucson Orthopedic Institute, P.C.
Tucson, Arizona, United States, 85172
3
Providence Clinical Research
Burbank, California, United States, 91505
4
100 UCLA Medical Plaza, Suite 305
Los Angeles, California, United States, 90024