Administration of Two Injections for Multiple Dupuytren's Contractures

Completed · Phase 3

Conditions studied: Dupuytren's Contracture

In brief

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 by palpable cords.

Key facts

Study ID: NCT01407068
Run by: Endo USA Inc., a Keenova Therapeutics Company
People needed: 60
Starts: 2011-09-01
Expected to finish: 2012-02-01
Last updated by the study team: 2017-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Tucson Orthopaedic Institute — Tucson, Arizona, United States
The Indiana Hand Center — Indianapolis, Indiana, United States
Department of Orthopaedics SUNY-Stony Brook — Stony Brook, New York, United States
Health Research Institute — Oklahoma City, Oklahoma, United States
AusTrials — Auchenflower, Australia
AusTrials — Auchenflower, Australia
AusTrials — Kippa-Ring, Australia
Emeritus Research — Malvern, Australia

Full record on ClinicalTrials.gov

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