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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2001 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
State University of New York
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004409
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: May 2001
  Purpose

OBJECTIVES:

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 Intervention Phase
Dupuytren's Contracture
Drug: collagenase
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 36
Study Start Date: August 1995
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004409

Locations
United States, California
Stanford University Hospital Recruiting
Palo Alto, California, United States, 94304
Contact: Vincent R Hentz    650-723-3731      
United States, New York
State University of New York Health Sciences Center - Stony Brook Recruiting
Stony Brook, New York, United States, 11790-7775
Contact: Lawrence C. Hurst    631-444-2215      
Sponsors and Collaborators
State University of New York
Investigators
Study Chair: Lawrence C. Hurst State University of New York
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004409     History of Changes
Other Study ID Numbers: 199/13297, SUNY-SB-FDR001373, DUPY-101, DUPY-202, SUNY-SB-431-1007A, SUNY-SB-431-8804B, SUNY-SB-431-X2020
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 24, 2014