Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder
NCT ID: NCT02006719
Last Updated: 2017-10-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
322 participants
INTERVENTIONAL
2013-11-30
2014-12-31
Brief Summary
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Detailed Description
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Approximately 300 adult women and men are to be enrolled in this study. Following screening and determination of study eligibility, subjects will be randomized 3:1 to receive 0.58 mg of AA4500 or placebo. Subjects will receive up to 3 injections of study drug. Each injection will be separated by a minimum of 21 days. Subjects will also be instructed in home shoulder exercises after the first injection.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Collagenase Clostridium Histolyticum
Up to 3 injections of .58 mg/1 mL of collagenase clostridium histolyticum (CCH), minimum of 21 days apart and home shoulder exercise.
Collagenase Clostridium Histolyticum
Treatment of Adhesive Capsulitis
Placebo
Up to 3 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise.
Placebo
Placebo injection
Interventions
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Collagenase Clostridium Histolyticum
Treatment of Adhesive Capsulitis
Placebo
Placebo injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal range of motion in the contralateral shoulder
* Restricted active range of motion (AROM) in the affected shoulder defined as: a deficit of at least 60 degrees in total AROM in the affected shoulder as compared with the total AROM in the contralateral shoulder and a deficit of at least 30 degrees in AROM in at least one of the following planes as compared with the contralateral shoulder:
* Forward flexion
* Abduction
* External rotation with the elbow up to 90 degrees abduction
* Internal rotation with the elbow up to 90 degrees abduction
Exclusion Criteria
* physical therapy or acupuncture within 2 weeks before the first injection of study drug
* intra-articular or intrabursal injection(s) of lidocaine; suprascapular nerve blocks; corticosteroids, electroanalgesic and/or thermoanalgesic modalities within 1 month before the screening visit
* intra-articular or intrabursal injection(s) of sodium hyaluronate and/or glenohumeral distension arthrography within 3 months before the screening visit
* surgical intervention (including shoulder manipulation under anesthesia) at any time
* Has any of the following conditions, as determined by investigator to be potentially confounding to the evaluation of safety and efficacy:
* Adhesive capsulitis as a result of traumatic injury (ie, direct injury to the shoulder such as fracture of the humerus or clavicle immediately preceding the onset of this episode of adhesive capsulitis). Traumatic events in the past that are not temporally related to the onset of this episode of adhesive capsulitis would not necessarily exclude a subject from participating in the study.
* Active subacromial impingement in the affected shoulder
* Calcified tendonitis in the affected shoulder
* Glenohumeral joint arthritis in the affected shoulder
* Arthrosis of the affected shoulder
* Chondrolysis of the affected shoulder
* Subscapularis tendon rupture of the affected shoulder
* Other rotator cuff injuries of the affected shoulder
* Uncontrolled hypertension
* Uncontrolled diabetes
* Uncontrolled thyroid disease
* History of thrombosis or post-thrombosis syndrome
* Physical impairment that would preclude performing the protocol defined exercises
* Active infection in area to be treated
* Clinically significant neurological disease
* Bleeding disorder
* Chronic use of anticoagulation medications and the subject cannot be cleared medically to stop taking medication for 7 days prior to each injection. Less than or equal to 150 mg aspirin is allowed during the study.
* Known active hepatitis A, B, or C
* Other significant medical condition (eg, morbid obesity, cervical disc disease), which in the investigator's opinion would make the subject unsuitable for enrollment in the study
* Has received oral or intravenous steroids for any reason within 3 weeks before the screening visit
* Has received an investigational drug or treatment within 30 days before the first dose of study drug.
* Has a known allergy to collagenase or any other excipient of AA4500 or any other procedural medication.
* Has, at any time, received collagenase for the treatment of adhesive capsulitis.
* Is unable to undergo an x-ray or MRI (contraindication) evaluation of the affected shoulder.
* Is planning to be treated with commercial XIAFLEX at any time during the study.
18 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Neil H Schusterman, MD FACP
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Alabama Orthopaedic Center-Research
Birmingham, Alabama, United States
Coastal Clinical Research
Mobile, Alabama, United States
Arizona Research Center, Inc.
Phoenix, Arizona, United States
Advance Med Clinical Research
Carlsbad, California, United States
Triwest Research Associates
El Cajon, California, United States
Core Orthopedic Medical Center
Encinitas, California, United States
Temecula Rheumatology & Internal Medicine
Murrieta, California, United States
Clearview Medical Research
Santa Clarita, California, United States
Colorado Orthopedic Consultants, PC
Englewood, Colorado, United States
Florida Research Associates
DeLand, Florida, United States
Shrock Orthopedic Research, LLC
Fort Lauderdale, Florida, United States
Jewett Orthopedic Clinic
Orlando, Florida, United States
Clinical Research of West Florida
Tampa, Florida, United States
Non-Surgical Orthopedics, P.C. / Georgia Institute for Clinical Research, LLC
Marietta, Georgia, United States
Injury Care Medical Center
Boise, Idaho, United States
Rockford Orthopedic Associates
Rockford, Illinois, United States
Rockford Orthopedics Associates
Rockford, Illinois, United States
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States
PRN of Kansas
Wichita, Kansas, United States
Central Kentucky Research Associates
Lexington, Kentucky, United States
Bone and Joint Clinic
Gretna, Louisiana, United States
MedPharmics, LLC
Metairie, Louisiana, United States
Arthritis and Rheumatism Associates, PC
Wheaton, Maryland, United States
Great Falls Clinic
Great Falls, Montana, United States
Nevada Orthopedic & Spine Center
Las Vegas, Nevada, United States
Stony Brook University Medical Center (SUNY)
Stony Brook, New York, United States
Triangle Orthopedic Associates, PA
Durham, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
The Neuromusculoskeletal Center of the Cascades d.b.a. The Center
Bend, Oregon, United States
Blair Orthopedic Associates, Inc.
Altoona, Pennsylvania, United States
University of Pennsylvania Penn Orthopaedics
Philadelphia, Pennsylvania, United States
Texas Orthopedic Specialist
Bedford, Texas, United States
Centex Studies
Houston, Texas, United States
Commonwealth Orthopaedics & Rehabilitation
Arlington, Virginia, United States
Danville Orthopedic Clinic, Inc.
Danville, Virginia, United States
Sports Medicine Professionals
Richmond, Victoria, Australia
Hunter Clinical Research
NSW, , Australia
Royal Prince Alfred
NSW, , Australia
St George Hospital
NSW, , Australia
Peninsula Private Hospital
Queensland, , Australia
QPharm
Queensland, , Australia
Menzies Research Institute
Tasmania, , Australia
Emeritus Research
VIC, , Australia
Epworth Hospital
VIC, , Australia
Repatriation Hospital
VIC, , Australia
Hand and Upper Limb Centre
WA, , Australia
Countries
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Other Identifiers
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AUX-CC-871
Identifier Type: -
Identifier Source: org_study_id