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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 to evaluate the efficacy and safety of bromocriptine hydrochloride spray in the treatment of 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] Primary study objective:
Compared with celecoxib capsules, to evaluate the efficacy of bromocriptine hydrochloride spray in the treatment of target knee osteoarthritis in subjects treated with bromocriptine hydrochloride spray for 12 weeks.
Secondary study objective:
To evaluate the safety of bromocriptine 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 drug-controlled Phase II clinical study to evaluate the preliminary efficacy and safety of X0002 in the treatment of 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] Primary study objective: To evaluate the relief of target knee osteoarthritis pain in X0002-treated subjects by measuring the Western Ontario and McMaster Universities Osteoarthritis Inventory (WOMAC) pain scale score at 12 weeks after treatment.
比较盐酸布洛胺喷雾剂与布洛芬乳膏剂单次外用给药在健康受试者中的药代动力学特征的Ⅰ期研究
[Translation] Phase I study comparing the pharmacokinetic characteristics of a single topical administration of ibuprofen hydrochloride spray and ibuprofen cream in healthy subjects
本试验主要目的是比较盐酸布洛胺喷雾剂和5%布洛芬乳膏单次外用后的药代动力学特征。次要目的是比较盐酸布洛胺喷雾剂和5%布洛芬乳膏单次外用后的安全性和耐受性。
[Translation] The primary objective of this trial was to compare the pharmacokinetic characteristics of ibuprofen hydrochloride spray and 5% ibuprofen cream after a single topical application. The secondary objective was to compare the safety and tolerability of ibuprofen hydrochloride spray and 5% ibuprofen cream after a single topical application.
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