[Translation] Evaluation of the efficacy and safety of cross-linked sodium hyaluronate injection BTM002 compared with Aldrin in the treatment of patients with knee osteoarthritis pain who are unresponsive to non-drug and general analgesics: a multicenter, randomized, double-blind, parallel, positive-controlled phase III clinical study
· 主要研究目的:以阿尔治(Artz)为对照(1周1次,共5次),评价交联玻璃酸钠注射液BTM002单次给药治疗保守性非药物治疗及一般镇痛剂治疗无效的膝骨关节炎疼痛患者的有效性;
· 次要研究目的:以阿尔治(Artz)为对照(1周1次,共5次),评价交联玻璃酸钠注射液BTM002单次给药治疗保守性非药物治疗及一般镇痛剂治疗无效的膝骨关节炎疼痛患者的安全性。
[Translation] · Primary study purpose: Using Artz as a control (once a week, 5 times in total), evaluate the effectiveness of a single dose of cross-linked sodium hyaluronate injection BTM002 in treating patients with knee osteoarthritis pain who have failed conservative non-drug treatment and general analgesics;
· Secondary study purpose: Using Artz as a control (once a week, 5 times in total), evaluate the safety of a single dose of cross-linked sodium hyaluronate injection BTM002 in treating patients with knee osteoarthritis pain who have failed conservative non-drug treatment and general analgesics.