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
8100 Northland Drive
Minneapolis, Minnesota 55431
624
mi
from 43215
Minneapolis, MN
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1044 SW 44th Street
Oklahoma City, Oklahoma 73109
405-616-4888
851
mi
from 43215
Oklahoma City, OK
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980 Johnson Ferry Road Northeast
Atlanta, Georgia 30342
424
mi
from 43215
Atlanta, GA
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75 Francis Street
Boston, Massachusetts 02115
640
mi
from 43215
Boston, MA
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Denver, Colorado 80210
?
mi
from 43215
Denver, CO
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213
mi
from 43215
Erie, PA
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Indianapolis, Indiana 46260
167
mi
from 43215
Indianapolis, IN
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100 Medical Plaza Driveway
Los Angeles, California 90095
1982
mi
from 43215
Los Angeles, CA
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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
480
mi
from 43215
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...
635
mi
from 43215
Newton, MA
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795 El Camino Real
Palo Alto, California 94304
2100
mi
from 43215
Palo Alto, CA
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222 Richmond Street
Providence, Rhode Island 02905
619
mi
from 43215
Providence, RI
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Rockford, Illinois 61107
351
mi
from 43215
Rockford, IL
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State College, Pennsylvania 16801
277
mi
from 43215
State College, PA
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100 Nicolls Road
Stony Brook, New York 11794
524
mi
from 43215
Stony Brook, NY
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