Spots Global Cancer Trial Database for AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture
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Trial Identification
Brief Title: AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture
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
Study ID: NCT00528606
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Veronica Urdaneta, MD
Affiliation: Endo Pharmaceuticals
Role: STUDY_DIRECTOR
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