[Translation] A multicenter, randomized, double-blind, placebo-controlled, active drug-controlled, parallel-group phase III clinical study to evaluate the efficacy and safety of diclofenac epolamide patch in the treatment of local soft tissue injuries (strains, sprains, and contusions)
主要目的:以氟比洛芬凝胶贴膏(泽普思®)为阳性对照药,评价双氯芬酸依泊胺贴治疗局部软组织损伤(拉伤、扭伤、挫伤)的临床疗效非劣效性;以安慰剂为对照,评价双氯芬酸依泊胺贴治疗局部软组织损伤(拉伤、扭伤、挫伤)临床疗效的优效性;
次要目的:评价双氯芬酸依泊胺贴治疗局部软组织损伤(拉伤、扭伤、挫伤)患者的安全性。
[Translation] Primary objective: To evaluate the non-inferiority of the clinical efficacy of diclofenac epamide patch in the treatment of local soft tissue injuries (strains, sprains, and contusions) using flurbiprofen gel patch (Zeps®) as a positive control drug; to evaluate the superiority of the clinical efficacy of diclofenac epamide patch in the treatment of local soft tissue injuries (strains, sprains, and contusions) using placebo as a control;
Secondary objective: To evaluate the safety of diclofenac epamide patch in the treatment of patients with local soft tissue injuries (strains, sprains, and contusions).