None listed
Conditions
Brief summary
This study will examine the safety and pharmacokinetics (the study of the way the body absorbs, distributes: and gets rid of the drug) of AA4500 following concurrent administration of two injections of AA4500 0.58mg into the same hand of subjects with Dupuytren's contractures and palpable cords.
Interventions
The components of AA4500 are: mixed collagenase AUX I and AUX II, sucrose. The components of the sterile diluent are: 0.03% calcium chloride in 0.9% sodium chloride. Each dose of AA4500 is 0.58mg. The Drug is injected directly into the cord using a 27 gauge (13mm) needle. This is a single dose drug.
Sponsors
Auxilium Phamaceuticals, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Provide written informed consent 2. Be a man or woman greater than of equal to18 years of age and less than or equal to 70 years 3. Have a diagnosis of Dupuytren’s disease and have at least 3 fixed-flexion contractures (2 must be on the same hand) that are = 20 degrees in PIP and/or MP joints in fingers, other than the thumbs, which are caused by palpable cords 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. Be naive to AA4500 treatment 6. 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) 7. 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 8. 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 90 days before the first injection of AA4500 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 other collagenase treatments (eg, Santyl (Registered Trademark) ointment) within 30 days before injection of AA4500 5. 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 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. Has significant renal or hepatic impairment, which in the opinion of the investigator, could compromise the scientific objectives of the study 8. Is known to be immunocompromised or human immunodeficiency virus (HIV) positive 9. Has a history of illicit drug abuse or alcoholism within the year before injection of AA4500 10. Has a positive alcohol breath test or a positive urine drug screen within 3 days before admission to the study unit 11. Received an investigational drug within 30 days before injection of AA4500 12. Is a pregnant or lactating female 13. 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 14. Has jewelry on the hand to be treated that cannot be removed 15. Requires a local anesthetic before injection of AA4500 or before the finger extension procedure in multiple-dose Period 2
Outcome results
None listed