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



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:12/3/2017
Start Date:August 2007
End Date:April 2008

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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

This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the
United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal
(MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at
least one finger, other than the thumb, that was at least 20° as measured by finger
goniometry and was suitable for injection were randomized 2:1 to receive AA4500 0.58 mg or
placebo.

This study was designed to be part of the larger clinical program, for adult patients with
Dupuytren's contracture with a palpable cord, where the data from 2 pivotal
Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7
non-pivotal studies were evaluated.


Inclusion Criteria:

- Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity
of at least one finger, other than the thumb, that had a contracture at least 20°, but
not greater than 100°, for MP (80° for PIP) joints, caused by a palpable cord that had
never been treated with AA4500.

- Had a 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:

- Had a chronic muscular, neurological, or neuromuscular disorder that affected the
hands.

- Had 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.

- Had a known recent history of stroke, bleeding, a disease process that affected the
hands, or other medical condition, which in the investigator's opinion, would make the
subject unsuitable for enrollment in the study.
We found this trial at
15
sites
100 Nicolls Road
Stony Brook, New York 11794
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1044 SW 44th Street
Oklahoma City, Oklahoma 73109
405-616-4888
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Oklahoma City, OK
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980 Johnson Ferry Road Northeast
Atlanta, Georgia 30342
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Atlanta, GA
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75 Francis Street
Boston, Massachusetts 02115
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Boston, MA
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Denver, Colorado 80210
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Denver, CO
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Erie, PA
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Indianapolis, Indiana 46260
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Indianapolis, IN
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100 Medical Plaza Driveway
Los Angeles, California 90095
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Los Angeles, CA
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8100 Northland Drive
Minneapolis, Minnesota 55431
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Minneapolis, MN
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, NY
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2014 Washington St
Newton, Massachusetts 02462
(617) 243-6000
Newton-Wellesley Hospital A comprehensive medical center located right in Newton on Washington Street, Newton-Wellesley Hospital...
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Newton, MA
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795 El Camino Real
Palo Alto, California 94304
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Palo Alto, CA
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222 Richmond Street
Providence, Rhode Island 02905
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Providence, RI
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Rockford, Illinois 61107
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Rockford, IL
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State College, Pennsylvania 16801
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State College, PA
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