NCT00528606

AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren's Contracture

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 308 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture 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 injection were randomized 2:1 to receive AA4500 0.58 mg or placebo. 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

• Dupuytren's Contracture

Interventions

Type	Name	Description
BIOLOGICAL	collagenase clostridium histolyticum	Subjects could have received up to three injections of AA4500 into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
BIOLOGICAL	Placebo	Subjects could have received up to three injections of placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-09-12
• Last updated: 2017-12-02
• Results posted: 2010-10-22

Locations

15 sites across 1 country: United States