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AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture (CORD-I)

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ClinicalTrials.gov Identifier: NCT00528606
Recruitment Status : Completed
First Posted : September 12, 2007
Results First Posted : October 22, 2010
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Brief Summary:

This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture 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 injection were randomized 2:1 to receive AA4500 0.58 mg or placebo.

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.


Condition or disease Intervention/treatment Phase
Dupuytren's Contracture Biological: collagenase clostridium histolyticum Biological: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AA4500 0.58 mg Biological: 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.
Other Names:
  • XIAFLEX®
  • AA4500
Placebo Comparator: Placebo Biological: 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.



Primary Outcome Measures :
  1. Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection [ Time Frame: Within 30 days after the last injection ]

    The Primary Outcome Measure for patients treated with AA4500 is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.

    The Primary Outcome Measure for placebo treated patients is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection.



Secondary Outcome Measures :
  1. Clinical Improvement After the Last Injection [ Time Frame: Baseline; within 30 days after the last injection ]
    Clinical Improvement is defined as >= 50% reduction from baseline in degree of contracture within 30 days of the injection.

  2. Percent Reduction From Baseline Contracture After the Last Injection [ Time Frame: Baseline; within 30 days after the last injection ]
    Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.

  3. Change From Baseline Range of Motion After the Last Injection [ Time Frame: Baselin; within 30 days after the last injection ]
    Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.

  4. Time to First Achieve Success After the Last Injection [ Time Frame: Last evaluation visit on which clinical success is achieved through the Day 30 evaluation ]
  5. Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection [ Time Frame: Within 30 days after first injection ]
    Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection.

  6. Clinical Improvement After the First Injection [ Time Frame: Baseline; within 30 days after the first injection ]
    Clinical Improvement is defined as >= 50% reduction from contracture within 30 days of the first injectionor greater of baseline contracture within 30 days of the injection.

  7. Percent Reduction From Baseline Contracture After the First Injection [ Time Frame: Baseline, within 30 days after the first injection ]
    Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture.

  8. Change From Baseline Range of Motion After the First Injection [ Time Frame: Baseline; within 30 days after the first injection ]
    Change in degree of motion measured as last available post-injection range of motion - baseline range of motion.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100°, for MP (80° for PIP) joints, caused by a palpable cord that had never been treated with AA4500.
  • 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 a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528606


Locations
United States, California
100 UCLA Medical Plaza, Suite 305
Los Angeles, California, United States, 90095
Hand Surgery Clinic
Palo Alto, California, United States, 94304
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
Brigham and Women's Hospital, Department of Orthopedic Surgery
Boston, Massachusetts, United States, 02115
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
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
Hand Microsurgery & Reconstructive Orthopaedics
Erie, Pennsylvania, United States, 16550
University Orthopedics Center
State College, Pennsylvania, United States, 16801
United States, Rhode Island
Department of Orthopaedics, Brown University, Rhode Island Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Veronica Urdaneta, MD Endo Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00528606     History of Changes
Other Study ID Numbers: AUX-CC-857
First Posted: September 12, 2007    Key Record Dates
Results First Posted: October 22, 2010
Last Update Posted: December 2, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases