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.|
|ClinicalTrials.gov Identifier: NCT00004409|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Study Start Date :||August 1995|
|Estimated Study Completion Date :||April 2004|
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 ClinicalTrials.gov identifier (NCT number): 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|