Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease
Dupuytren's Contracture
About this trial
This is an interventional treatment trial for Dupuytren's Contracture focused on measuring Dupuytren's disease, arthritis & connective tissue diseases, rare disease
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of residual stage Dupuytren's disease with fixed flexion deformity of the finger(s) 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-- At least 30 days since prior surgery for Dupuytren's disease At least 30 days since prior participation in a trial with an 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, angina, or myocardial infarction within the past 6 months Pulmonary: No history of respiratory disease Other: Not immunocompromised HIV negative No history of significant illness (e.g., endocrine or neurologic disease) No psychosis No history of illicit drug abuse or alcoholism within the past year No infectious illness within the past 2 weeks No chronic or debilitating disease No IgE antibodies to collagenase exceeding 15 ng/mL No known allergy to collagenase or any of the inactive ingredients in the drug No other condition or circumstance that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception