Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
NCT ID: NCT00528840
Last Updated: 2017-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
201 participants
INTERVENTIONAL
2007-10-31
2008-10-31
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AA4500 0.58 mg
collagenase clostridium histolyticum
Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days.
Interventions
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collagenase clostridium histolyticum
Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
* Were naïve to AA4500 treatment or had received one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in Auxilium Studies AUX-CC-851, AUX-CC-853, or AUX-CC-855.
* Were judged to be in good health.
Exclusion Criteria
* Had received treatment for advanced Dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of AA4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.
* 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.
18 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Veronica Urdaneta, MD
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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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
Countries
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Related Links
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XIAFLEX Prescribing Information
Other Identifiers
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AUX-CC-856
Identifier Type: -
Identifier Source: org_study_id