Spots Global Cancer Trial Database for Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
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
Conditions
Interventions
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
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
