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Spots Global Cancer Trial Database for Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease

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Trial Identification

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

Official Title: A Phase 3, Open-Label Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease

Study ID: NCT00528840

Study Description

Brief Summary: 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Veronica Urdaneta, MD

Affiliation: Endo Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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