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Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价盐酸布洛胺喷雾剂治疗膝关节骨关节炎患者的疗效和安全性的多中心、随机双盲、安慰剂以及阳性药对照的Ⅲ期临床研究
[Translation] A multicenter, randomized double-blind, placebo and active drug-controlled phase III clinical study evaluating the efficacy and safety of ibuprofen hydrochloride spray in patients with knee osteoarthritis
主要研究目的:
与塞来昔布胶囊相比较,在盐酸布洛胺喷雾剂治疗12周时,评价盐酸布洛胺喷雾剂治疗受试者目标膝关节骨关节炎的疗效。
次要研究目的:
评估盐酸布洛胺喷雾剂在膝关节骨关节炎受试者中的安全性。
[Translation] Main research purpose:
To evaluate the efficacy of ibuprofen hydrochloride spray in the treatment of subjects' target knee osteoarthritis when compared with celecoxib capsules at 12 weeks of treatment with ibuprofen hydrochloride spray.
Secondary research purposes:
To evaluate the safety of ibuprofen hydrochloride spray in subjects with knee osteoarthritis.
评价X0002治疗膝关节骨关节炎患者的初步疗效和安全性的多中心、随机双盲、安慰剂以及阳性药对照的II期临床研究
[Translation] A multicenter, randomized, double-blind, placebo- and active-controlled phase II clinical study to evaluate the preliminary efficacy and safety of X0002 in patients with knee osteoarthritis
主要研究目的:在治疗后12周时,通过测定西安大略和麦克马斯特大学骨关节炎调查量表(WOMAC)疼痛量表评分,评价X0002治疗受试者目标膝关节骨关节炎疼痛的缓解情况。
[Translation] MAIN STUDY OBJECTIVE: To evaluate the relief of pain in target knee osteoarthritis in X0002-treated subjects by measuring the Western Ontario and McMaster Universities Osteoarthritis Questionnaire (WOMAC) pain scale scores at 12 weeks post-treatment Condition.
A Phase 2, Multicenter, Double-blind and Placebo and Active Control Study to Evaluate the Initial Efficacy and Safety of X0002 Spray in Treatment of Subjects With Osteoarthritis of the Knee
This study is a randomized, double-blind clinical trial in a Chinese population.
100 Clinical Results associated with Tianjin XinChen-Techfields Pharma Co., LTD.
0 Patents (Medical) associated with Tianjin XinChen-Techfields Pharma Co., LTD.
100 Deals associated with Tianjin XinChen-Techfields Pharma Co., LTD.
100 Translational Medicine associated with Tianjin XinChen-Techfields Pharma Co., LTD.