Status:
COMPLETED
Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Dupuytren's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objectives of this study are to assess the safety and effectiveness of AA4500 in treating palmar Dupuytren's disease nodules.
Detailed Description
Approximately 13 sites in the United States and Australia, approximately 90 study subjects. After all pre-injection procedures are completed on day 1, eligible men and women will be randomized in a 1...
Eligibility Criteria
Inclusion
- 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 one palmar nodule on the selected hand that is:
- Palpable
- Measures between 0.5 cm and 2.0 cm in length and between 0.5 cm and 2.0 cm in width using hand-held calipers n
- Not directly associated with a Dupuytren's cord
- 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
Exclusion
- Received steroid injections (eg, tri-amcinolone acetonide) on the selected nodule within 3 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
- Had surgery on the selected hand within 3 months before the screening visit
- Has jewelry on the hand to be treated that cannot be removed
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT02193828
Start Date
July 1 2014
End Date
December 1 2014
Last Update
October 5 2017
Active Locations (11)
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1
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
2
CORE Orthopaedic Medical Center
Encinitas, California, United States, 92024
3
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States, 94904
4
Brigid Freyne, MD, Inc.
Murrieta, California, United States, 92563