Spots Global Cancer Trial Database for AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
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Trial Identification
Brief Title: AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
Official Title: A Phase 3, Open-Label Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
Study ID: NCT00528424
Conditions
Interventions
Study Description
Brief Summary: Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857 (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less, the cord affecting that joint received less than three injections of AA4500, or they had other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option to receive up to five injections of AA4500 in this extension study. Subjects requiring further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each injection, with injections separated by four weeks. Follow-up visits for the determination of efficacy and safety were conducted on Day 90, Month 6, and Month 9. 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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