AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder

Exclusion Criteria

• •1. Is a pregnant or lactating female or female intending to become pregnant during the study
• •2. Is a male who intends to father a child during the study
• •3. 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
• •4. 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
• •* Known active hepatitis B or C (history of hepatitis A permitted)
• •* 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
• •5. Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits.
• •6. Has received oral or intravenous steroids for any reason within 3 weeks before the screening visit
• •7. Has received an investigational drug or treatment within 30 days before the first dose of study drug.
• •8. Has a known systemic allergy to collagenase or any other excipient of AA4500 or any other procedural medication.
• •9. Has, at any time, received collagenase for the treatment of adhesive capsulitis.
• •10. Is unable to undergo an x-ray or MRI (contraindication) evaluation of the affected shoulder.
• •11. Is planning to be treated with commercial Xiaflex at any time during the study.