NCT00479505已完成2 期
A Multi-Center, Randomised, Parallel Group, Double-Blind, Placebo Controlled Estimation Study To Assess The Efficacy And Safety Of Modified Release UK-369,003 In The Treatment Of Men With Storage Lower Urinary Tract Symptoms (LUTS) With And Without Erectile Dysfunction (ED).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- This is an estimation study with no primary endpoint. There are efficacy endpoints.
研究概览
简要总结
This is a 12 week study in which different doses of UK-369,003 will be administered to patients with a diagnosis of overactive bladder. Patients will complete a series of questionnaires before treatment, during treatment and after treatment, to assess whether UK-369,003 has improved their symptoms of overactive bladder and erectile function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects aged 18 years and above
- •documented clinical diagnosis of overactive bladder with urinary frequency >= 8 times / 24 hours and number of urgency episodes > 1 episode / 24 hours.
排除标准
- •Neurological diseases known to affect bladder function.
- •Urinary tract infection.
研究组 & 干预措施
Active
Experimental
干预措施: UK-369,003 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
This is an estimation study with no primary endpoint. There are efficacy endpoints.
时间窗: 12 Weeks
次要结局
- Patient perception of bladder control questionnaire.(12 Weeks)
- International index of erectile function questionnaire.(12 Weeks)
- International consultation on incontinence questionnaire.(12 Weeks)
- Patient reported treatment impact questionnaire.(12 Weeks)
- Lower urinary tract symptoms diary.(12 Weeks)
- International prostate symptom score questionnaire.(12 Weeks)
- OAB-q short form questionnaire.(12 Weeks)
- Quality of erection questionnaire.(12 Weeks)
研究者
研究点 (1)
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