Collagenase in the Treatment of Dupuytrens Disease

This study is not yet open for participant recruitment.

Verified by Stony Brook University, November 2005

Sponsors and Collaborators:	Stony Brook University Biospecifics Technologies Corp.
Information provided by:	Stony Brook University
ClinicalTrials.gov Identifier:	NCT00260429

Purpose

The purpose of the study is to determine if collagenase injection(s) will straighten the finger contractures associated with Dupuytren's disease.

Condition	Intervention	Phase
Dupuytren's Disease With a Minimum 20 Degree Joint Flexion Contracture of One or More Fingers.	Drug: Collagenase	Phase III

Drug Information available for: Collagenase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Stony Brook University:

Primary Outcome Measures:

Primary outcome measure is reduction of flexion contracture.

Estimated Enrollment:	232
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2007

Detailed Description:

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

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

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosis of Dupuytrens disease
minimum 20 degree contracture(s) of the MP and/or PIP joints in any finger excluding the thumb

Exclusion Criteria:

any chronic, serious or uncontrolled medical condition
inability to conform to study visits (20-30 per year)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260429

Contacts

Contact: Marie A Badalamente	631 444 2215	mbadalamente@notes.cc.sunysb.edu
Contact: Gail Trocchio	631 444 2215	gtrocchio@notes.cc.sunysb.edu

Locations

United States, California
UCLA Medical Center
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
United States, Michigan
Ford Institute
Detroit, Michigan, United States

Sponsors and Collaborators

Stony Brook University

Biospecifics Technologies Corp.

More Information

Publications:

Badalamente MA, Hurst LC, Hentz VR. Collagen as a clinical target: nonoperative treatment of Dupuytren's disease. J Hand Surg [Am]. 2002 Sep;27(5):788-98.

Study ID Numbers:	DUPY 303
Study First Received:	November 29, 2005
Last Updated:	November 29, 2005
ClinicalTrials.gov Identifier:	NCT00260429
Health Authority:	United States: Food and Drug Administration

Keywords provided by Stony Brook University:

Dupuytren's contracture
Finger Flexion contracture

Study placed in the following topic categories:

Muscular Diseases
Musculoskeletal Diseases
Contracture
Joint Diseases

Connective Tissue Diseases
Dupuytren's Contracture
Dupuytren's contracture

ClinicalTrials.gov processed this record on January 14, 2009