NL-OMON31014撤回3 期
12-week, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, multicenter trial to evaluate the efficacy and safety of fesoterodine in comparison to tolterodine ER in patients with overactive bladder. - A0221008
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Pfizer
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •- Overactive bladder symptoms for more than 3 months prior to screening/enrolment visit (visit 1)
- •- Reported at least an everage of 1 UUI episode per 24 hours in the 3-day micturition diary prior to the randomization/baseline visit (visit 2)
排除标准
- •-Any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment, severe ulcerative colitis, and toxic megacolon.
- •-Clinically significant hepatic or renal disease, and/or with a screening test of AST,ALT, ALP, urea nitrogen, or creatinine greater than 1.5 times of the upper limit of normal range (ULN)
- •See for more exclusion criteria p.19-21
研究者
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