CompletedPhase 3

Administration of Two Injections for Multiple Dupuytren's Contractures

United States, Australia60 participantsStarted 2011-09

Plain-language 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 by palpable cords.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Percent Change From Baseline in Total Fixed Flexion

Timeframe: 30 days after last injection

Change in Total Range of Motion

Timeframe: 30 days after last injection

Trial details

NCT IDNCT01407068

SponsorEndo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-02

Results submitted2015-02-04

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