AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture
NCT ID: NCT00528606
Last Updated: 2017-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
308 participants
INTERVENTIONAL
2007-08-31
2008-04-30
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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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AA4500 0.58 mg
collagenase clostridium histolyticum
Subjects could have received up to three injections of AA4500 into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
Placebo
Placebo
Subjects could have received up to three injections of placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
Interventions
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collagenase clostridium histolyticum
Subjects could have received up to three injections of AA4500 into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
Placebo
Subjects could have received up to three injections of placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections.
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.
* Judged to be in good health.
Exclusion Criteria
* Had received a treatment for Dupuytren's contracture, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
* 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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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
Countries
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References
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Witthaut J, Bushmakin AG, Gerber RA, Cappelleri JC, Le Graverand-Gastineau MP. Determining clinically important changes in range of motion in patients with Dupuytren's Contracture: secondary analysis of the randomized, double-blind, placebo-controlled CORD I study. Clin Drug Investig. 2011 Nov 1;31(11):791-8. doi: 10.1007/BF03256918.
Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866.
Related Links
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XIAFLEX Prescribing Information
Other Identifiers
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AUX-CC-857
Identifier Type: -
Identifier Source: org_study_id