Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder

Completed · Phase 2 · Has a placebo group

Conditions studied: Adhesive Capsulitis, Frozen Shoulder

In brief

The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.

Key facts

Study ID

NCT02006719

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

322

Starts

2013-11-01

Expected to finish

2014-12-01

Last updated by the study team

2017-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unilateral idiopathic adhesive capsulitis of one shoulder for at least 3 months but not more than 12 months (Frozen Stage)
• 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

You may not qualify if…

• Has received treatment for adhesive capsulitis or is planning to receive treatment for adhesive capsulitis at any time during the study including but not limited to:
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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