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

Completed · Phase 3

Conditions studied: Advanced Dupuytren's Disease

In brief

This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a diagnosis of advanced Dupuytren's disease 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 evaluation and injection were enrolled. 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.

Key facts

Study ID

NCT00528840

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

201

Starts

2007-10-01

Expected to finish

2008-10-01

Last updated by the study team

2017-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with a diagnosis of advanced Dupuytren's disease, 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.
• Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
• Were naïve to AA4500 treatment or had received one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in Auxilium Studies AUX-CC-851, AUX-CC-853, or AUX-CC-855.
• Were judged to be in good health.

You may not qualify if…

• Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
• Had received treatment for advanced Dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of AA4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.
• 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.

Where it is running

• Hope Research Institute — Phoenix, Arizona, United States
• Tucson Orthopedic Institute, P.C. — Tucson, Arizona, United States
• Providence Clinical Research — Burbank, California, United States
• Southern Illinois Hand Center, S.C. — Effingham, Illinois, United States
• Rockford Orthopedic Associates, Ltd. — Rockford, Illinois, United States
• The Indiana Hand Center — Indianapolis, Indiana, United States
• Pri Via — Wichita, Kansas, United States
• St. Alexius Medical Center — Bismarck, North Dakota, United States
• David R. Mandel, Inc. — Mayfield, Ohio, United States
• St. Vincent Medical Center — Portland, Oregon, United States
• Hamot Center for Clinical Research — Erie, Pennsylvania, United States
• Alpha Clinical Research — Clarksville, Tennessee, United States
• The Rheumatic Disease Clinic of Houston — Houston, Texas, United States
• Accurate Clincal Research — Houston, Texas, United States

Full record on ClinicalTrials.gov

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