[Translation] Evaluation of the efficacy and safety of cross-linked sodium hyaluronate injection BTM002 compared with butylated hyaluronate cross-linked sodium hyaluronate injection in patients with knee osteoarthritis pain: a multicenter, randomized, double-blind, parallel, positive-controlled clinical study.
主要研究目的:以丁甘交联玻璃酸钠注射液单次给药治疗为对照,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:以丁甘交联玻璃酸钠注射液单次给药治疗为对照,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 objective: To evaluate the efficacy of a single dose of cross-linked sodium hyaluronate injection (BTM002) in treating knee osteoarthritis pain unresponsive to conservative non-pharmacological treatment and conventional analgesics, using a single dose of cross-linked sodium hyaluronate injection as a control. Secondary objective: To evaluate the safety of a single dose of cross-linked sodium hyaluronate injection (BTM002) in treating knee osteoarthritis pain unresponsive to conservative non-pharmacological treatment and conventional analgesics, using a single dose of cross-linked sodium hyaluronate injection as a control.