An Open-label Study to Assess the Safety and Efficacy of Concurrent Administration of Two Injections of AA4500 0.58 mg Into the Same Hand of Subjects With Multiple Dupuytren's Contractures
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Dupuytren's Contracture
- Sponsor
- Endo Pharmaceuticals
- Enrollment
- 60
- Locations
- 6
- Primary Endpoint
- Percent Change From Baseline in Total Fixed Flexion
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 by palpable cords.
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 palpable cords in the same hand will be enrolled. After all pre-injection procedures are completed on Day 1, eligible men and women will receive two concurrent injections of AA4500 0.58 mg into the same hand. On Day 2, a finger extension procedure to facilitate cord disruption will be performed in those subjects who do not have spontaneous disruption of their cord(s). Follow-up visits for the evaluation of safety and efficacy will be on Day 8, Day 30, and Day 60. Upon completion of the Day 60 follow-up visit, subjects who require further treatment will have the option to receive three additional open-label treatments according to the XIAFLEX package insert (Appendix C). Subjects may receive up to a total of five injections and individual cords may receive up to a total of three injections.
Investigators
Eligibility Criteria
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
- •Received an investigational drug within 30 days before injection of AA4500
- •Is a pregnant or lactating female
Outcomes
Primary Outcomes
Percent Change From Baseline in Total Fixed Flexion
Time Frame: 30 days after last injection
Total fixed flexion is defined as the sum of the fixed flexion contractures of the two joints receiving treatment. Change in fixed-flexion contracture is measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees
Change in Total Range of Motion
Time Frame: 30 days after last injection
The total range of motion is the sum of the range of motion measurements of the two treated joints. Range of motion is defined as difference between full flexion angle and full extension angle expressed in degrees.
Secondary Outcomes
- Clinical Success by Joint Type(30 days after injection)
- Subject Satisfaction With Treatment(60 days after last injection)
- Investigator Assessment of Improvement With Treatment(60 days after last injection)