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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 [624 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...

Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?

This study evaluates if hand therapy have an impact on the patients' preformance of and satisfaction with everyday activities or not following collagenase injection treatment for Dupuytren...

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.

PubMed Articles [2209 Associated PubMed Articles listed on BioPortfolio]

Dupuytren Disease: Is Collagenase Better Than Needling?: Commentary on an article by Joakim Strömberg, MD, et al.: "Percutaneous Needle Fasciotomy Versus Collagenase Treatment for Dupuytren Contracture. A Randomized Controlled Trial with a Two-Year Follow-up".

Dupuytren's Contracture: An Evidence Based Review.

Dupuytren's contracture, a benign condition characterized by fibrosis of the palmar and digital fascia, may be a debilitating condition that limits daily function. Several techniques exist for managin...

Percutaneous Needle Fasciotomy Versus Collagenase Treatment for Dupuytren Contracture: A Randomized Controlled Trial with a Two-Year Follow-up.

Local disruption of the cord that causes contracture of the finger in Dupuytren disease can be achieved either through mechanical division by percutaneous needle fasciotomy (PNF) or through enzymatic ...

Use of Dorsal Skin Islands as Firebreak Grafts to the Palm to Reduce the Recurrence Rate of Dupuytren's Contracture.

Dupuytren's pathologic tissue usually involves the palmar skin and rarely infiltrates into the dorsal skin. In this study, we hypothesized that transplantation of a vascularized cutaneous flap harvest...

Dupuytren's disease: limited fasciectomy, night splinting, and hand exercises-long-term results.

Dupuytren's contracture (DC) is a fibroproliferative disorder of palmar fascia that causes flexion contractures of one or more digits. There is currently no gold standard operative and postoperative p...

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).

Adverse reactions that occur initially at the site of injection or infusion. Milder type is confined to a local allergic flare reaction. A more severe reaction is caused by extravasation of VESICANTS from the blood vessel at the site of injection and can cause damage to the surrounding tissue. In tumor flare reaction symptoms involve well beyond the injection site such as an increase in the tumor size and tumor markers levels, bone pain, and HYPERCALCEMIA.

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.

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