EP-104IAR-201是一项随机、双盲、安慰剂对照的临床试验,研究对象为318名膝骨关节炎患者(163名接受EP-104IAR治疗,155名接受安慰剂治疗),其Kellgren-Lawrence疼痛分级为2-3级,中重度疼痛评分由WOMAC疼痛评分(4-9)进行评估。 图片来源:123RF 该研究的主要终点是EP-104IAR治疗组和安慰剂组在12周时
Methods: 318 subjects with KOA pain were randomized 1:1 to receive a single IA dose of EP-104IAR 25mg (n=163), or vehicle (n=155) in one index knee and were followed for 24 weeks. The study enrolled males and females, ≥40 years, diagnosed with primary KOA with a Kellgren-...