At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 38 enrolled

Drug / intervention

collagenase clostridium histolyticumbiological

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00260429

NCT00260429Phase 3Completed

Compare CT.gov

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

Stony Brook University·interventional·Posted Dec 1, 2005·Updated Dec 9, 2010

In Brief

A Phase 3 clinical trial evaluating collagenase clostridium histolyticum for Dupuytren's Disease. Completed, enrolled 38 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDupuytren's Disease

CountriesUnited States

CollaboratorsBiospecifics Technologies Corp., Endo Pharmaceuticals

Timeline

Phase 3CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2003

Primary CompletionAug 2005

First PostedDec 2005

Study CompletionApr 2008

TodayJul 2026

First PostedDec 1, 2005

Enrollment StartJun 1, 2003

Primary CompletionAug 1, 2005

Study CompletionApr 1, 2008

TodayJul 2, 2026

Enrollment to primary: 2.2 yearsPosted 20.6 years ago

Interventions

collagenase clostridium histolyticumbiological

Subjects could have received up to three injections of AA4500/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.