Advanced Dupuytren's Disease Clinical Trial
Official title:
A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a
diagnosis of advanced Dupuytren's disease in a metacarpophalangeal (MP) or proximal
interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one
finger, other than the thumb, that was at least 20° as measured by finger goniometry and was
suitable for evaluation and injection were enrolled.
This study was designed to be part of the larger clinical program, for adult patients with
Dupuytren's contracture with a palpable cord, where the data from 2 pivotal
Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7
non-pivotal studies were evaluated.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00528424 -
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
|
Phase 3 | |
| Completed |
NCT00533273 -
Non-US Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
|
Phase 3 |