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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.
Allocation: Randomized, Control: Placebo Control, Primary Purpose: Treatment
Not yet recruiting
FDA Office of Orphan Products Development
Published on BioPortfolio: 2014-07-23T21:56:00-0400
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.
The purpose of the study is to determine if collagenase injection(s) will straighten the finger contractures associated with Dupuytren's disease.
Trial is a prospective, randomized, controlled, outcome assessor-blinded, three armed parallel 1:1:1, multicenter trial. The research objective is to determine, which treatment strategy 1)...
Phase 3, open-label study conducted in United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint tha...
A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's contracture conducted at one site in the United States. Pharmacokinetic blood samples will be collecte...
Dupuytren's contracture produces a progressive flexion contracture of the affected fingers. Collagenase Clostridium histolyticum produces breakdown of the cord in the hand and/or finger(s) that tighte...
The aim of this meta-analysis was to assess the safety and efficacy of collagenase clostridium histolyticum compared with fasciectomy and percutaneous needle fasciotomy (PNF) for Dupuytren's disease.
Dupuytren's disease is a common benign fibromatosis of the palmar and digital fascia. The exact pathophysiology and epidemiology of this condition have not been entirely identified. Pathologic fibrous...
Pseudo-boutonniere deformity is an uncommon complication from long-standing proximal interphalangeal (PIP) joint contracture in Dupuytren disease. Prolonged flexion contracture of the PIP joint can le...
A fibromatosis of the palmar fascia characterized by thickening and contracture of the fibrous bands on the palmar surfaces of the hand and fingers. It arises most commonly in men between the ages of 30 and 50.
Surgical incision on the FASCIA. It is used to decompress compartment pressure (e.g. in COMPARTMENT SYNDROMES; circumferential burns and extremity injuries) or to release contractures (e.g. in DUPUYTREN'S CONTRACTURE).
A secreted endopeptidase homologous with INTERSTITIAL COLLAGENASE, but which possesses an additional fibronectin-like domain.
A species of gram-positive, strongly proteolytic bacteria in the family Clostridiaceae. It contains several forms of COLLAGENASE whose action can lead to GAS GANGRENE in humans and HORSES.
Persistent flexure or contracture of a joint. (Dorland, 27th ed)
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...