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news.Auxilium Pharmaceuticals has dosed first patient in Phase IIa trial of XIAFLEX (collagenase clostridium histolyticum) to treat idiopathic adhesive capsulitis of the shoulder, known as Frozen Shoulder syndrome.
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The syndrome is a condition of the shoulder in which increased capsular collagen thickening and subsequent capsular contraction in the shoulder joint may cause loss of range of motion.
The study is an open-label, dose-ranging study designed to measure Safety and efficacy of XIAFLEX.
The study’s primary endpoint is the change (degrees) from baseline to the day 92 follow-up in forward flexion (active) in the affected shoulder.
Safety assessments, including immunogenicity testing, will be made during all study visits.
Auxilium chief medical officer James Tursi said that the shoulder joint is crucial for many activities and when its function becomes limited, it can have a significant impact on patients’ daily living.