NCT00528840

Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease

A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Dupuytren's Disease

Interventions

Type	Name	Description
BIOLOGICAL	collagenase clostridium histolyticum	Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days.

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-09-12
• Last updated: 2017-12-02
• Results posted: 2010-10-22

Locations

14 sites across 1 country: United States