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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.
Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment
Stanford University Hospital
FDA Office of Orphan Products Development
Published on BioPortfolio: 2014-08-27T03:58:14-0400
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...
Phase 3, double-blind, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal (MP) joint or a Proximal inter...
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...