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

2014-08-27 03:58:14 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Dupuytren's Contracture

Intervention

collagenase

Location

Stanford University Hospital
Palo Alto
California
United States
94304

Status

Recruiting

Source

FDA Office of Orphan Products Development

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:14-0400

Clinical Trials [68 Associated Clinical Trials listed on BioPortfolio]

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.

Trial Comparing Treatment Strategies in Dupuytren's Contracture

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)...

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

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 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...

PubMed Articles [108 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).

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)

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