Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease
Completed
State University of New York
Phase 2
1995-08-01
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.
Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease
Completed
State University of New York
Phase 3
1969-12-31
OBJECTIVES: I. Compare the safety and efficacy of clostridial collagenase vs placebo in terms
of improving the degree of flexion deformity, range of finger motion, and grip strength in
patients with residual stage Dupuytren's disease.
II. Compare the overall clinical success rate, time to return to normal finger contracture to
within 0-5 degrees of normal (zero degrees), and frequency of cord rupture in the joint of
patients treated with these regimens.
III. Compare the baseline change in degree of finger flexion deformity, range of motion of
the treated finger, and strength of hand grip (in pounds) in patients treated with these
regimens.
IV. Compare the frequency distribution of the number of patients with reduction in finger
contracture to within 0-5 degrees of normal (zero degrees) and the number who require
re-treatment with open-label collagenase after treatment with these regimens.
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