Status:
COMPLETED
Administration of Two Injections for Multiple Dupuytren's Contractures
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Dupuytren's Contracture
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objectives of this study are to assess the safety and efficacy of concurrent administration of two injections of AA4500 into the same hand of subjects with multiple Dupuytren's contractures caused...
Detailed Description
Methodology/Study Design: This is an open-label, study in men and women with multiple Dupuytren's contractures. Approximately 60 subjects who have at least two Dupuytren's contractures caused by palp...
Eligibility Criteria
Inclusion
- Provide written 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 cords 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
- Either be using an accepted method of birth control (ie, surgical sterilization; intra uterine contraceptive device; oral contraceptive; diaphragm or condom in combination with contraceptive cream, or jelly or foam) and have negative pregnancy testing before administration of AA4500, if a female of childbearing potential, or be a postmenopausal female (no menses for at least 1 year or hysterectomy)
- Not have any clinically significant medical history or condition(s) 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
- Be able to comply with the study visit schedule as specified in the protocol
Exclusion
- Received surgery (fasciectomy or surgical fasciotomy) and/or needle aponeurotomy/fasciotomy on the selected joints to be treated within 90 days before the first injection of AA4500
- 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 AA4500
- Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for ≤ 150 mg aspirin daily and over-the-counter nonsteroidal anti-inflammatory drugs \[NSAIDs\]) within 7 days before injection of AA4500)
- 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
- Is known to be immunocompromised or human immunodeficiency virus (HIV) positive
- Has a history of illicit drug abuse or alcoholism within the year before injection of AA4500
- Received an investigational drug within 30 days before injection of AA4500
- Is a pregnant or lactating female
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01407068
Start Date
September 1 2011
End Date
February 1 2012
Last Update
October 5 2017
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
2
The Indiana Hand Center
Indianapolis, Indiana, United States, 46260
3
Department of Orthopaedics SUNY-Stony Brook
Stony Brook, New York, United States, 11794
4
Health Research Institute
Oklahoma City, Oklahoma, United States, 73109