Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures

Completed · Phase 3

Conditions studied: Dupuytren's Contracture

In brief

The primary objective of this study is to assess the safety of two concurrent injections of AA4500 into the same hand in subjects with multiple Dupuytren's contractures with palpable cords followed 24 to 72 hours later by a finger extension procedure and compare the rate of occurrence of targeted serious adverse events (tendon rupture/ligament injury and anaphylaxis) to historical rates of the same in clinical studies and post-marketing commercial use. The secondary objective is to evaluate the efficacy of two concurrent injections of AA4500.

Key facts

Study ID

NCT01674634

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

715

Starts

2012-09-01

Expected to finish

2013-07-01

Last updated by the study team

2017-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provide a signed and dated informed consent
• Be a man or woman ≥ 18 years of age
• 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
• Have a positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top
• 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).
• Be able to comply with the study visit schedule as specified in the protocol

You may not qualify if…

• A subject will be excluded from study participation if he/she:
• 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
• Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
• Has a known systemic allergy to collagenase or any other excipient of AA4500
• 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
• 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
• 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
• Received an investigational drug within 30 days before injection of study drug
• Is pregnant or intends on becoming pregnant during the study or is breastfeeding a child
• 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
• Has jewelry on the hand to be treated that cannot be removed

Where it is running

• 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

Full record on ClinicalTrials.gov

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