The purpose of the study is to determine if collagenase will reduce the degree of contracture in the primary joint in subjects with Dupuytren's disease. This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to disrupt the Dupuytren's cord. Resultant cord disruption may obviate the need for patients to have surgery to correct the finger flexion contractures of Dupuytren's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
Subjects could have received up to three injections of AA4500/placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
Stony Brook University Hospital and Mediacl Center
Stony Brook, New York, United States
Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.
The Primary Outcome Measure for patients treated with AA4500 is the percentage of 23 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less. The Primary Outcome Measure for placebo treated patients is the percentage of 12 joints that were successfully treated where "successfully treated" was defined as reduction in contracture to 5° or less.
Time frame: 30 days after the last injection
Percent Reduction From Baseline Contracture After the Last Injection
Time frame: 30 days after last treatment to the primary joint
Percent Change From Baseline Range of Motion After the Last Injection
Time frame: 30 days after last treatment to the primary joint
Time to First Achieve and Maintain Clinical Success After the Last Injection
Time frame: First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of the primary joint
Clinical Success After the First Injection
Time frame: 30 days after first treatment to the primary joint
Percent Reduction From Baseline Contracture After the First Injection
Time frame: 30 days after first treatment to the primary joint
Change From Baseline Range of Motion After the First Injection
Time frame: 30 days after first treatment to the primary joint
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