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Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture

2014-07-24 14:20:23 | BioPortfolio

Summary

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 that results in a fixed flexion deformity of at least one finger, other than the thumb, that is at least 20° as measured by finger goniometry will be enrolled.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Dupuytren's Contracture

Intervention

Clostridial Collagenase for Injection (AA4500)

Location

Hope Research Institute
Phoenix
Arizona
United States
85050

Status

Completed

Source

Auxilium Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:20:23-0400

Clinical Trials [552 Associated Clinical Trials listed on BioPortfolio]

AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture

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...

A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture

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...

AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture

Study AUX-CC-858 is an open-label continuation of the double-blind Study AUX-CC-857. Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 will enter int...

Collagenase in the Treatment of Dupuytrens Disease

The purpose of the study is to determine if collagenase injection(s) will straighten the finger contractures associated with Dupuytren's disease.

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

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.

PubMed Articles [2208 Associated PubMed Articles listed on BioPortfolio]

Skin Laceration in Collagenase Clostridium histolyticum Treatment for Dupuytren's Contracture.

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...

Efficacy and adverse effects of collagenase use in the treatment of Dupuytren's disease: a meta-analysis.

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 Contracture: Current Treatment Methods.

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...

Technique of Dynamic Flexor Digitorum Superficialis Transfer to Lateral Bands for Proximal Interphalangeal Joint Deformity Correction in Severe Dupuytren Disease.

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...

"Acute Dupuytren's contracture": the answer is not always in your hands.

Medical and Biotech [MESH] Definitions

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.

Total or subtotal destruction of the pituitary gland by chemical injection. It is usually achieved by injection of ethyl alcohol via trans-sphenoidal cannulation under stereotaxic control. It is usually performed for the treatment of intractable pain.

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.

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