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Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease
This study is not yet open for patient recruitment.
Sponsored by: | FDA Office of Orphan Products Development State University of New York
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Information provided by: | FDA Office of Orphan Products Development |
Purpose
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 | Treatment or Intervention | Phase |
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Dupuytren's Contracture |
Drug: collagenase |
Phase III |
MedlinePlus related topics: Connective Tissue Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Placebo Control
Expected Total Enrollment: 72
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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:
Location Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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