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Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004409
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:


Evaluate the safety and efficacy of collagenase in improving flexion deformity, range of motion, and grip strength in patients with residual Dupuytren's disease.

Condition or disease Intervention/treatment Phase
Dupuytren's Contracture Drug: collagenase Phase 2

Detailed Description:

PROTOCOL OUTLINE: This is a randomized, investigator-blinded, placebo-controlled study.

Patients receive a single dose of either collagenase or placebo into the target finger on day 0. Patients who do not respond at the 1 month follow up visit may receive an injection of open label collagenase, if IgE antibody levels are no greater than 15 ng/mL.

Following treatment, patients use a nighttime extension splint for 4 months and perform finger flexion/extension exercises. Patients are followed at 1, 7, and 14 days, and at 1, 2, 3, 6, 9, and 12 months, for each joint treated.

Completion date provided represents the completion date of the grant per OOPD records

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : August 1995
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--Disease Characteristics-- Diagnosis of residual Dupuytren's disease with fixed flexion deformity of the fingers of at least 20-30 degrees caused by a palpable cord Positive table top test (inability to simultaneously place affected finger and palm flat against a table top) --Prior/Concurrent Therapy-- Surgery: At least 30 days since surgery for Dupuytren's disease Other: At least 30 days since prior investigational drug --Patient Characteristics-- Hematopoietic: No history of hematologic disease Hepatic: No history of hepatic disease Renal: No history of renal disease Cardiovascular: No congestive heart failure within 6 months No angina within 6 months No myocardial infarction within 6 months Pulmonary: No history of respiratory disease Other: HIV negative Not immunocompromised No history of significant illness, e.g., endocrine or neurologic disease No history of illicit drug abuse or alcoholism within 1 year No psychosis At least 2 weeks since infectious illness No chronic or debilitating disease No IgE antibodies to collagenase greater than 15 ng/mL No known allergy to collagenase or any of the inactive ingredients in the injection Not pregnant or nursing Fertile patients must use effective contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004409

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United States, California
Stanford University Hospital
Palo Alto, California, United States, 94304
United States, New York
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-7775
Sponsors and Collaborators
State University of New York
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Study Chair: Lawrence C. Hurst State University of New York

Layout table for additonal information Identifier: NCT00004409     History of Changes
Other Study ID Numbers: 199/13297
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: May 2001

Keywords provided by FDA Office of Orphan Products Development:
Dupuytren's disease
arthritis & connective tissue diseases
rare disease

Additional relevant MeSH terms:
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Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Connective Tissue Diseases