Trials / Completed
CompletedNCT00954746
Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859
CORDLESS- Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 645 (actual)
- Sponsor
- Endo Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 open-label extension studies (AUX-CC-857/AUX-CC-858 and AUX-CC-859). After completion of one of the above mentioned studies, subjects are enrolled and followed once a calendar year for 4 consecutive years with at least 6 months between consecutive visits.
Conditions
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2013-05-01
- Completion
- 2013-05-01
- First posted
- 2009-08-07
- Last updated
- 2015-06-16
Locations
39 sites across 6 countries: United States, Australia, Denmark, Finland, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00954746. Inclusion in this directory is not an endorsement.