Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
Evaluate the safety and efficacy of collagenase in improving flexion deformity, range of motion, and grip strength in patients with residual Dupuytren's disease.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||August 1995|
|Estimated Study Completion Date:||April 2004|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004409
|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|
|Study Chair:||Lawrence C. Hurst||State University of New York|