Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease
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|ClinicalTrials.gov Identifier: NCT00014742|
Recruitment Status : Completed
First Posted : April 11, 2001
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Dupuytren's Contracture||Drug: collagenase||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|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): NCT00014742
|Study Chair:||Lawrence C. Hurst||State University of New York|