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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dupuytren's Contracture

In brief

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.

Key facts

Study ID

NCT00528606

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

308

Starts

2007-08-01

Expected to finish

2008-04-01

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 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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