Collagenase in the Treatment of Dupuytrens Disease

Dupuytren's Disease Clinical Trial

Official title: Double-blind, Randomized Placebo Controlled Study of the Relative Safety and Efficacy of Collagenase Therapy in the Treatment of Residual-type Dupuytren's Disease.

Status Completed

Clinical Trial Summary

The purpose of the study is to determine if collagenase will reduce the degree of contracture in the primary joint in subjects with Dupuytren's disease.

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 and AUX-CC-859) and 7 non-pivotal studies were evaluated.

Clinical Trial Description

In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to disrupt the Dupuytren's cord.

Resultant cord disruption may obviate the need for patients to have surgery to correct the finger flexion contractures of Dupuytren's disease. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dupuytren Contracture
• Dupuytren's Disease

• NCT number: NCT00260429
• Study type: Interventional
• Source: Stony Brook University
• Status: Completed
• Phase: Phase 3
• Start date: June 2003
• Completion date: April 2008