NCT00746681已完成2 期
A Phase 2, 26 Week, Multicentre, Randomized Double Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Tolterodine, Pregabalin and a Tolterodine-Pregabalin Combination for Idiopathic Overactive Bladder
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
- 188
- 试验地点
- 1
- 主要终点
- Change in mean voided volume per micturition (from baseline).
研究概览
简要总结
Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered when it is combined with tolterodine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women > 18 years Old
- •Diagnosis of OAB (micturition frequency >/= 8 times per day; urinary urgency >/= 4 times per week)
排除标准
- •Subjects with symptoms of overactive bladder for less than 6 months prior to randomization.
- •Significant stress incontinence as determined by the investigator e.g. stress predominant mixed incontinence, positive cough provocation test.
- •Subjects with any condition that would contraindicate the use of tolterodine or pregabalin, including: Uncontrolled narrow angle glaucoma; Urinary retention; Myasthenia gravis; Gastric retention; Severe ulcerative colitis; Toxic megacolon; Rare hereditary problems of galactose intolerance; Fructose intolerance; Sucrose-isomalate insufficiency; Lapp lactase deficiency; Glucose-galactose malabsorption.
研究组 & 干预措施
A
Experimental
Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily
干预措施: Tolterodine & Pregabalin (Drug)
B
Active Comparator
Tolterodine SR 4 mg once daily
干预措施: Tolterodine (Drug)
C
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
D
Experimental
Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily
干预措施: Tolterodine & Pregabalin (Drug)
E
Experimental
Pregabalin 150 mg twice daily
干预措施: Pregabalin (Drug)
结局指标
主要结局
Change in mean voided volume per micturition (from baseline).
时间窗: 4 weeks
次要结局
- Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline).(4 Weeks)
- Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale)(4 Weeks)
- Percentage and absolute change in urgency episode frequency(4 Weeks)
- Mean severity of urgency episodes(4 Weeks)
- Percentage and absolute change in micturition frequency(4 Weeks)
- Percentage and absolute change in normalized micturition frequency (NMF)(4 Weeks)
- Patient perception of their urinary urgency (using the OAB-q symptom severity scale)(4 Weeks)
- Patient Perception of Bladder Condition (PPBC) scale(4 Weeks)
研究者
研究点 (1)
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