Clinical trial NCT01407068: Administration of Two Injections for Multiple Dupuytren's Contractures
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dupuytren's Contracture
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent
2. Be a man or woman ≥ 18 years of age
3. 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
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. 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)
6. 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
7. 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 collagenase treatments (eg, Santyl® ointment and/or XIAFLEX/XIAPEX) 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. Is known to be immunocompromised or human immunodeficiency virus (HIV) positive
8. Has a history of illicit drug abuse or alcoholism within the year before injection of AA4500
9. Received an investigational drug within 30 days before injection of AA4500
10. Is a pregnant or lactating female
11. 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
12. Has jewelry on the hand to be treated that cannot be removed

Primary outcomes:
measure: Percent Change From Baseline in Total Fixed Flexion
timeFrame: 30 days after last injection
measure: Change in Total Range of Motion
timeFrame: 30 days after last injection
Secondary outcomes:
measure: Subject Satisfaction With Treatment
timeFrame: 60 days after last injection
measure: Investigator Assessment of Improvement With Treatment
timeFrame: 60 days after last injection
measure: Clinical Success by Joint Type
timeFrame: 30 days after injection
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Indianapolis
country: United States
facility: The Indiana Hand Center
state: Indiana
city: Stony Brook
country: United States
facility: Department of Orthopaedics SUNY-Stony Brook
state: New York
city: Oklahoma City
country: United States
facility: Health Research Institute
state: Oklahoma
city: Auchenflower
country: Australia
facility: AusTrials
city: Auchenflower
country: Australia
facility: AusTrials
city: Kippa Ring
country: Australia
facility: AusTrials
city: Malvern
country: Australia
facility: Emeritus Research
Study officials:
affiliation: Endo Pharmaceuticals
name: Veronica Urdaneta, MD, MPPH
role: STUDY_DIRECTOR
References: