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Dupuytren Contracture

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collagenase

Lawrence C. Hurst

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.

PROTOCOL OUTLINE: This is a randomized, investigator-blinded, placebo-controlled, multicenter study. Patients are randomized to one of two treatment arms.

Arm I: Patients receive a single collagenase injection into the target finger cord on day 0.

Arm II: Patients receive a single placebo injection as in arm I.

Both arms: After the 1 month evaluation, patients who are unresponsive to treatment may receive monthly injections of collagenase for a maximum of 5 injections.

Beginning at 1 day after completion of treatment, patients use a joint nighttime extension splint for 4 months and perform finger flexion/extension exercises.

Patients are followed at 1, 7, and 14 days, monthly for 3 months, every 3 months for 9 months, and then annually for 4 years.

Completion date provided represents the completion date of the grant per OOPD records

Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease

State University of New York

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.

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

Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease	NCT00014742	Dupuytren's Con...	collagenase	18 Years -	FDA Office of Orphan Products Development
Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease	NCT00004409	Dupuytren's Con...	collagenase	18 Years -	FDA Office of Orphan Products Development
Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease	NCT00014742	Dupuytren's Con...	collagenase	18 Years -	FDA Office of Orphan Products Development

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