AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder

Completed · Phase 2

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

NCT01483963

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

50

Starts

2011-11-01

Expected to finish

2013-02-01

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…

• Be a male or female and be greater than or equal to 18 years of age
• If a female of childbearing potential, have a negative urine pregnancy test and be using an effective contraception method (ie, abstinence, intrauterine device (IUD), hormonal (estrogen/progestin) contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for one menstrual cycle following end of study, or be surgically sterile
• Have unilateral idiopathic adhesive capsulitis of one shoulder for at least 3 months but not more than 12 months before the screening visit and be in Stage 2 (frozen or adhesive stage), as determined by the investigator
• Have normal range of motion in the contralateral shoulder, as determined by the investigator
• Have 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
• Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution.
• Be able to complete and understand the various rating instruments in English.

You may not qualify if…

• Is a pregnant or lactating female or female intending to become pregnant during the study
• Is a male who intends to father a child during the study
• 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 AA4500
• 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 within 3 months before the screening visit
• glenohumeral distension arthrography and/or surgical intervention (including shoulder manipulation under anesthesia) at any time
• Has any of the following conditions, as determined by the investigator:
• Adhesive capsulitis as a result of traumatic injury
• Pain in the affected shoulder at rest that is greater than or equal to 4 on the 11-point pain scale
• 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
• Coagulation disorder, using anticoagulant (except for less than or equal to 150 mg aspirin) within 7 days prior to each injection day

Where it is running

• Alabama Orthopaedic Center - Research — Birmingham, Alabama, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• Tucson Orthopaedic Institute — Tucson, Arizona, United States
• OrthoArkansas — Little Rock, Arkansas, United States
• CORE Orthopaedic Medical Center — Encinitas, California, United States
• Triwest Research Associates — La Mesa, California, United States
• Advent Clinical Research — Pinellas Park, Florida, United States
• Rockford Orthopedic Associates — Rockford, Illinois, United States
• The Indiana Hand to Shoulder Center — Indianapolis, Indiana, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• David R. Mandel, MD, Inc. — Cleveland, Ohio, United States
• Health Research Institute — Oklahoma City, Oklahoma, United States
• Blair Orthopedic Associates, Inc. — Altoona, Pennsylvania, United States
• Alpha Clinical Research, LLC — Clarksville, Tennessee, United States
• Basin Orthopedic Surgical Specialists — Odessa, Texas, United States

Full record on ClinicalTrials.gov

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