Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures
A Phase 3b Open-label, Historically-controlled Study to Assess the Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures With Palpable Cords
1 other identifier
interventional
715
1 country
25
Brief Summary
The primary objective of this study is to assess the safety of two concurrent injections of AA4500 into the same hand in subjects with multiple Dupuytren's contractures with palpable cords followed 24 to 72 hours later by a finger extension procedure and compare the rate of occurrence of targeted serious adverse events (tendon rupture/ligament injury and anaphylaxis) to historical rates of the same in clinical studies and post-marketing commercial use. The secondary objective is to evaluate the efficacy of two concurrent injections of AA4500.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2012
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2012
CompletedFirst Posted
Study publicly available on registry
August 29, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
February 20, 2015
CompletedOctober 5, 2017
September 1, 2017
10 months
August 27, 2012
February 4, 2015
September 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent Change From Baseline in Total Fixed Flexion
Percent change from baseline in total fixed flexion = 100 \* (baseline total FFC - day 31 total FFC)/baseline total FFC, where total fixed flexion is defined as the sum of the fixed flexion contracture (FCC) of the 2 joints receiving treatment. Positive percent change from baseline indicates improvement.
Baseline, Day 31
Change From Baseline in Total Range of Motion
The total range of motion (ROM) is the sum of the range of motion measurements of the 2 treated joints. ROM is defined as difference between full flexion angle and full extension expressed in degrees. A positive change from baseline indicates increased (improved) ROM.
Baseline, Day 31
Secondary Outcomes (8)
Clinical Success
Within 30 days
Clinical Improvement
Within 30 days
Subject Assessment of Satisfaction With Treatment at Day 31
Day 31
Subject Assessment of Satisfaction With Treatment at Day 61
Day 61
Investigator Assessment of Improvement With Treatment at Day 31
Day 31
- +3 more secondary outcomes
Study Arms (1)
XIAFLEX / XIAPEX
EXPERIMENTALAA4500 (collagenase clostridium histolyticum)
Interventions
injection (0.58 mg after reconstitution with sterile diluent \[0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride\])
Eligibility Criteria
You may qualify if:
- Provide a signed and dated 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 cord(s) 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
- Have a negative urine pregnancy test at screening and before injection of study drug and be using a highly effective (ie, \< 1% failure rate) contraception method as judged by the investigator (eg, abstinence, intrauterine device \[IUD\], hormonal \[estrogen/progestin\] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study or be surgically sterile (if female of childbearing potential); or be a postmenopausal female (no menses for at least 1 year or hysterectomy).
- Be able to comply with the study visit schedule as specified in the protocol
You may not qualify if:
- A subject will be excluded from study participation if he/she:
- Received surgery (fasciectomy or surgical fasciotomy) and/or needle aponeurotomy/fasciotomy on the selected joints to be treated within 6 months before administration of study drug
- 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 study drug in the hand selected for treatment
- Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for ≤ 150 mg aspirin daily) within 7 days before injection of study drug
- 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
- Received an investigational drug within 30 days before injection of study drug
- Is pregnant or intends on becoming pregnant during the study or is breastfeeding a child
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
HOPE Research Institute
Phoenix, Arizona, 85018, United States
Tucson Orthopaedic Institute
Tucson, Arizona, 85712, United States
CORE Orthopaedic Medical Center
Encinitas, California, 92024, United States
Torrey Pines Medical Group
La Jolla, California, 92037, United States
Brigid Freyne, MD, Inc.
Murrieta, California, 92563, United States
The Hand and Upper Extremity Center
Atlanta, Georgia, 30342, United States
Rockford Orthopedic Associates
Rockford, Illinois, 61107, United States
The Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Christine M. Kleinert Institute for Hand and Microsurgery, Inc.
Louisville, Kentucky, 40202, United States
Lake Cumberland Rheumatology
Somerset, Kentucky, 42503, United States
TRIA Orthopedic Center
Minneapolis, Minnesota, 55431, United States
Missoula Bone and Joint
Missoula, Montana, 59808, United States
Nevada Orthopedic and Spine Center
Las Vegas, Nevada, 89128, United States
Central Jersey Hand Surgery
Eatontown, New Jersey, 07724, United States
Hospital for Special Surgery
New York, New York, 10021, United States
SUNY Stony Brook
Setauket, New York, 11733, United States
UNC School of Medicine
Chapel Hill, North Carolina, 27599, United States
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, 28207, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
The Center for Neurosurgical and Orthopedic Care and Research
Bend, Oregon, 97701, United States
Hand Microsurgery & Reconstructive Orthopaedics
Erie, Pennsylvania, 16507, United States
Alpha Clinical Research, LLC
Clarksville, Tennessee, 37043, United States
Accurate Clinical Research, Inc.
Houston, Texas, 77034, United States
The Arthritis Clinic of Northern Virginia, PA
Arlington, Virginia, 22205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Coordinator
- Organization
- Endo Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Veronica Urdaneta, MD, MPPH
Endo Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2012
First Posted
August 29, 2012
Study Start
September 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
October 5, 2017
Results First Posted
February 20, 2015
Record last verified: 2017-09