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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 [486 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 [2100 Associated PubMed Articles listed on BioPortfolio]

Benefit of Local Anesthesia in Reducing Pain during Collagenase Injection for Dupuytren's Contracture.

Collagenase injection for Dupuytren's contracture is commonly administered without anesthesia. The authors studied the benefit of injecting local anesthesia before collagenase in reducing treatment-re...

Dupuytren's contracture and handwork: A case-control study.

The objective of this study was to examine the association between Dupuytren's contracture (DC), repetitive handwork (RHW), heavy handwork (HHW), and/or vibration exposure.

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...

Treatment of Dupuytren's disease with collagenase injections in Germany: efficacy and adverse effects in 110 treated joints.

Background Since 2011, a new minimally-invasive treatment for Dupuytren's disease has been available in the form of injectable collagenase (Xiapex®, Pfizer). Purpose Our aim is to report about the re...

Recurrence of Dupuytren's contracture: A consensus-based definition.

One of the major determinants of Dupyutren disease (DD) treatment efficacy is recurrence of the contracture. Unfortunately, lack of agreement in the literature on what constitutes recurrence makes it ...

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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