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Collagenase in the Treatment of Dupuytrens Disease

NCT00260429 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2010-12-09

Study results available
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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.

Conditions

  • Dupuytren's Disease

Interventions

BIOLOGICAL

collagenase clostridium histolyticum

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.

Sponsors & Collaborators

  • Biospecifics Technologies Corp.

    collaborator INDUSTRY

  • Endo Pharmaceuticals

    collaborator INDUSTRY

  • Stony Brook University

    lead OTHER

Principal Investigators

  • Lawrence C Hurst, MD · Stony Brook University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2005-08-31
Completion
2008-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00260429 on ClinicalTrials.gov