Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures
NCT ID: NCT01674634
Last Updated: 2017-10-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
715 participants
INTERVENTIONAL
2012-09-30
2013-07-31
Brief Summary
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The secondary objective is to evaluate the efficacy of two concurrent injections of AA4500.
Detailed Description
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Follow up visits for the evaluation of safety and efficacy will be required for all subjects 24 to 72 hours after injection, and on Days 15, 31, and 61.
Upon completion of the day 61 follow-up visit (end of study visit), subjects who require additional treatment in the treated hand may receive up to three additional injections of AA4500 according to the XIAFLEX package insert. Subjects may receive up to a total of five injections and individual cords may receive up to a total of three injections. Subjects who require additional treatment will be followed for safety.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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XIAFLEX / XIAPEX
AA4500 (collagenase clostridium histolyticum)
XIAFLEX / XIAPEX
injection (0.58 mg after reconstitution with sterile diluent \[0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride\])
Interventions
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XIAFLEX / XIAPEX
injection (0.58 mg after reconstitution with sterile diluent \[0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride\])
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Be a man or woman ≥ 18 years of age
3. Have a diagnosis of Dupuytren's disease and have at least 2 fixed-flexion contractures on the same hand that are ≥ 20º in PIP and/or MP joints in fingers, other than the thumbs, which are caused by palpable cord(s) suitable for treatment
4. Have a positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top
5. Have a negative urine pregnancy test at screening and before injection of study drug and be using a highly effective (ie, \< 1% failure rate) contraception method as judged by the investigator (eg, abstinence, intrauterine device \[IUD\], hormonal \[estrogen/progestin\] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study or be surgically sterile (if female of childbearing potential); or be a postmenopausal female (no menses for at least 1 year or hysterectomy).
6. Be able to comply with the study visit schedule as specified in the protocol
Exclusion Criteria
1. Received surgery (fasciectomy or surgical fasciotomy) and/or needle aponeurotomy/fasciotomy on the selected joints to be treated within 6 months before administration of study drug
2. Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
3. Has a known systemic allergy to collagenase or any other excipient of AA4500
4. Has received any collagenase treatments (eg, Santyl® ointment and/or XIAFLEX®/XIAPEX®) within 30 days before injection of study drug in the hand selected for treatment
5. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for ≤ 150 mg aspirin daily) within 7 days before injection of study drug
6. Has a known recent history of stroke, bleeding, or other medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study
7. Received an investigational drug within 30 days before injection of study drug
8. Is pregnant or intends on becoming pregnant during the study or is breastfeeding a child
9. Has any clinically significant medical history or condition(s), including conditions that affect the hands, that would, in the opinion of the investigator, substantially increase the risk associated with the subject's participation in the protocol or compromise the scientific objectives of the study
10. Has jewelry on the hand to be treated that cannot be removed
18 Years
ALL
Yes
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Veronica Urdaneta, MD, MPPH
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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HOPE Research Institute
Phoenix, Arizona, United States
Tucson Orthopaedic Institute
Tucson, Arizona, United States
CORE Orthopaedic Medical Center
Encinitas, California, United States
Torrey Pines Medical Group
La Jolla, California, United States
Brigid Freyne, MD, Inc.
Murrieta, California, United States
The Hand and Upper Extremity Center
Atlanta, Georgia, United States
Rockford Orthopedic Associates
Rockford, Illinois, United States
The Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Christine M. Kleinert Institute for Hand and Microsurgery, Inc.
Louisville, Kentucky, United States
Lake Cumberland Rheumatology
Somerset, Kentucky, United States
TRIA Orthopedic Center
Minneapolis, Minnesota, United States
Missoula Bone and Joint
Missoula, Montana, United States
Nevada Orthopedic and Spine Center
Las Vegas, Nevada, United States
Central Jersey Hand Surgery
Eatontown, New Jersey, United States
Hospital for Special Surgery
New York, New York, United States
SUNY Stony Brook
Setauket, New York, United States
UNC School of Medicine
Chapel Hill, North Carolina, United States
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, United States
Health Research Institute
Oklahoma City, Oklahoma, United States
The Center for Neurosurgical and Orthopedic Care and Research
Bend, Oregon, United States
Hand Microsurgery & Reconstructive Orthopaedics
Erie, Pennsylvania, United States
Alpha Clinical Research, LLC
Clarksville, Tennessee, United States
Accurate Clinical Research, Inc.
Houston, Texas, United States
The Arthritis Clinic of Northern Virginia, PA
Arlington, Virginia, United States
Countries
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Other Identifiers
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AUX-CC-867
Identifier Type: -
Identifier Source: org_study_id