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| Sponsor: | Auxilium Pharmaceuticals |
|---|---|
| Information provided by: | Auxilium Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00528606 |
Purpose
Phase 3, double-blind, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal (MP) joint or a Proximal interphalangeal (PIP) joint that results in a fixed flexion deformity of at least one finger, other than the thumb, that is at least 20° as measured by finger goniometry will be randomized 2:1 to receive AA4500 or placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Dupuytren's Contracture |
Biological: Clostridial Collagenase for Injection (AA4500) or placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 3, Double Blind, Randomized, Placebo Controlled Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Dupuytren's Contracture |
| Enrollment: | 308 |
| Study Start Date: | September 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Clostridial Collagenase for Injection (AA4500)
|
Biological: Clostridial Collagenase for Injection (AA4500) or placebo
Up to 3 injections of AA4500/placebo into the cord of the affected hand. Each injection separated by at least 30 days. Individual cords may receive up to a maximum of 3 injections.
|
| 2: Placebo Comparator |
Biological: Clostridial Collagenase for Injection (AA4500) or placebo
Up to 3 injections of AA4500/placebo into the cord of the affected hand. Each injection separated by at least 30 days. Individual cords may receive up to a maximum of 3 injections.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Hand Surgery Clinic | |
| Palo Alto, California, United States, 94304 | |
| 100 UCLA Medical Plaza, Suite 305 | |
| Los Angeles, California, United States, 90095 | |
| United States, Colorado | |
| Hand Surgery Associates, PC | |
| Denver, Colorado, United States, 80210 | |
| United States, Georgia | |
| The Hand and Upper Extremity Center of Georgia, P.C. | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| Rockford Orthopedic Associates, Ltd. | |
| Rockford, Illinois, United States, 61107 | |
| United States, Indiana | |
| The Indiana Hand Center | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Massachusetts | |
| Newton-Wellesley Hospital | |
| Newton, Massachusetts, United States, 02462 | |
| Brigham and Women's Hospital, Department of Orthopedic Surgery | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Minnesota | |
| TRIA Orthopaedic Center | |
| Minneapolis, Minnesota, United States, 55431 | |
| United States, New York | |
| Hospital for Special Surgery | |
| New York, New York, United States, 10021 | |
| SUNY Stony Brook - Department of Orthopedics | |
| Stony Brook, New York, United States, 11794 | |
| United States, Oklahoma | |
| Health Research Institute | |
| Oklahoma city, Oklahoma, United States, 73109 | |
| United States, Pennsylvania | |
| University Orthopedics Center | |
| State College, Pennsylvania, United States, 16801 | |
| Hand Microsurgery & Reconstructive Orthopaedics | |
| Erie, Pennsylvania, United States, 16550 | |
| United States, Rhode Island | |
| Department of Orthopaedics, Brown University, Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02905 | |
| Study Director: | John Rodzvilla, MD | Auxilium Pharmaceuticals, Inc. |
More Information
| Responsible Party: | Auxilium Pharmaceuticals, Inc. ( John Rodzvilla/ Vice President, Medical Development ) |
| Study ID Numbers: | AUX-CC-857 |
| Study First Received: | September 11, 2007 |
| Last Updated: | May 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00528606 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Muscular Diseases Musculoskeletal Diseases Contracture |
Joint Diseases Connective Tissue Diseases Dupuytren's Contracture |