Endo Int'l Reports Top-line Results From Phase 2 Study Of CCH For Adhesive Capsulitis Of Shoulder
(RTTNews) - Pharmaceutical company Endo International plc (ENDP) announced Friday top-line results from its Phase 2 study of Collagenase Clostridium Histolyticum (CCH) in participants with adhesive capsulitis (AC) of the shoulder, commonly known as "frozen shoulder."
The Phase 2 study participants receiving up to three doses of CCH showed some improvement in the change from baseline in the adapted American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Form composite score for the affected shoulder at the Day 95 visit.
The difference compared to those study participants receiving placebo was not statistically significant.
The safety profile of CCH in the Phase 2 study was consistent with the known safety profile from other studies.
The Phase 2 trial enrolled 198 participants with unilateral idiopathic AC of the shoulder with restricted range of motion (ROM) and function in the affected shoulder. Participants were randomized 1:1 to receive CCH or placebo administered by ultrasound-guided injection.
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