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

Sponsor:	Auxilium Pharmaceuticals
Information provided by:	Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00528606

Purpose

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 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 randomized 2:1 to receive AA4500 or placebo.

Condition	Intervention	Phase
Dupuytren's Contracture	Biological: Clostridial Collagenase for Injection (AA4500) or placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Double Blind, Randomized, Placebo Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren's Contracture

Resource links provided by NLM:

Drug Information available for: Collagenase

U.S. FDA Resources

Further study details as provided by Auxilium Pharmaceuticals:

Primary Outcome Measures:

Clinical success of the primary joint [ Time Frame: Within 30 days after the last injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical improvement of the primary joint. [ Time Frame: Within 30 days after the last injection ] [ Designated as safety issue: No ]
Percent reduction from baseline in contracture of the primary joint. [ Time Frame: Within 30 days after the last injection ] [ Designated as safety issue: No ]
Percent change from baseline in range of motion of the primary joint. [ Time Frame: Within 30 days after the last injection ] [ Designated as safety issue: No ]
Time to reach clinical success of the primary joint. [ Time Frame: Within 30 days after the last injection ] [ Designated as safety issue: No ]

Enrollment:	308
Study Start Date:	September 2007
Study Completion Date:	May 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Clostridial Collagenase for Injection (AA4500)	Biological: Clostridial Collagenase for Injection (AA4500) or placebo Up to 3 injections of AA4500/placebo into the cord of the affected hand. Each injection separated by at least 30 days. Individual cords may receive up to a maximum of 3 injections.
2: Placebo Comparator	Biological: Clostridial Collagenase for Injection (AA4500) or placebo Up to 3 injections of AA4500/placebo into the cord of the affected hand. Each injection separated by at least 30 days. Individual cords may receive up to a maximum of 3 injections.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Dupuytren's contracture with a fixed flexion deformity of at least one finger, other than the thumb, that is at least 20° or no greater than 100° for MP (80° for PIP) contracture, caused by a palpable cord that has never been treated with AA4500.
Positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
Judged to be in good health.

Exclusion Criteria:

A chronic muscular, neurological, or neuromuscular disorder that affects the hands.
Received a treatment for Dupuytren's contracture including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
A known recent history of stroke, bleeding, a disease process that affects the hands, or other medical condition which in the investigator's opinion would make the subject unsuitable for enrollment in the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528606

Locations

United States, California
Hand Surgery Clinic
Palo Alto, California, United States, 94304
100 UCLA Medical Plaza, Suite 305
Los Angeles, California, United States, 90095
United States, Colorado
Hand Surgery Associates, PC
Denver, Colorado, United States, 80210
United States, Georgia
The Hand and Upper Extremity Center of Georgia, P.C.
Atlanta, Georgia, United States, 30342
United States, Illinois
Rockford Orthopedic Associates, Ltd.
Rockford, Illinois, United States, 61107
United States, Indiana
The Indiana Hand Center
Indianapolis, Indiana, United States, 46260
United States, Massachusetts
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
Brigham and Women's Hospital, Department of Orthopedic Surgery
Boston, Massachusetts, United States, 02115
United States, Minnesota
TRIA Orthopaedic Center
Minneapolis, Minnesota, United States, 55431
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
SUNY Stony Brook - Department of Orthopedics
Stony Brook, New York, United States, 11794
United States, Oklahoma
Health Research Institute
Oklahoma city, Oklahoma, United States, 73109
United States, Pennsylvania
University Orthopedics Center
State College, Pennsylvania, United States, 16801
Hand Microsurgery & Reconstructive Orthopaedics
Erie, Pennsylvania, United States, 16550
United States, Rhode Island
Department of Orthopaedics, Brown University, Rhode Island Hospital
Providence, Rhode Island, United States, 02905

Sponsors and Collaborators

Auxilium Pharmaceuticals

Investigators

Study Director:

John Rodzvilla, MD

Auxilium Pharmaceuticals, Inc.

More Information

No publications provided by Auxilium Pharmaceuticals

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79.

Responsible Party:	Auxilium Pharmaceuticals, Inc. ( John Rodzvilla/ Vice President, Medical Development )
Study ID Numbers:	AUX-CC-857
Study First Received:	September 11, 2007
Last Updated:	May 27, 2009
ClinicalTrials.gov Identifier:	NCT00528606 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Muscular Diseases
Musculoskeletal Diseases
Contracture

Joint Diseases
Connective Tissue Diseases
Dupuytren's Contracture

ClinicalTrials.gov processed this record on February 08, 2010