NCT01833663已完成4 期
Multi-site, Randomized, Opened and Controlled Comparison Study on the Effectiveness and Safety of Solifenacin Succinate Tablets and Solifenacin Succinate Tablets + Estrogen for Overactive Bladder in the Post-menopausal Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Difference between the mean urination times (24h) at the end of treatment and the baseline value
研究概览
简要总结
This study is a multi-site, randomized, opened and parallel-controlled clinical study.
The patients up to the inclusion criteria are randomly treated with Solifenacin Succinate Tablets (5mg/d) or Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks. Before the dosing and at Week 4, 8 and 12 of the dosing, various examinations are made, and various indices are evaluated.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women aged ≤
- •Signing of ICF.
- •Willing to and able to correctly complete the urination diary.
- •Complications of OAB for ≥12 weeks (including: urgent micturition, frequent urination (≥8 times in the daytime, and ≥2 times at the night) and/or urgent urinary incontinence).
- •No dosing of other drugs of same kind within 14d. -≥8 urination times (24h) in the 1d urination diary.
排除标准
- •Clinically-significant dysuria(at the investigators' viewpoints).
- •Serious stress urinary incontinence or mixed stress/urgent urinary incontinence (mainly stress one) confirmed by the investigators.
- •At the ongoing intubatton or the intermittent self-intubatton.
- •Evidence-based urinary tract infection or chronic inflammation in the recent 2 weeks (e.g. interstitial cystitis), bladder calculus, past pelvic radiotherapy, and past or existing pelvic malignant tumors.
- •Uncontrolled narrow-angle glaucoma, urinary/gastric retention, intestinal obstruction and other medical symptoms forbidden for anti-cholinergic drugs at the investigators' viewpoints.
- •Non-pharmacotherapy (including electrotherapy) or bladder training within 2 weeks before the study initiation (or during the study).
- •Dosing of diuretics and drugs with the cholinergic or anti-cholinergic adverse reactions
- •Known or suspicious allergy to Solifenacin Succinate, other anti-cholinergic drugs or lactose.
- •Clinically-significant symptoms inapplicable for clinical study at the investigators' viewpoints.
- •Participation in other clinical studies within 30d before the random grouping.
- •No completion of urination diary according to relevant instructions.
- •Potentially clinically significant abnormalities (PCSA) inapplicable for clinical study at the investigators' viewpoints.
研究组 & 干预措施
Solifenacin Succinate Tablets and Estrogen capsules
Experimental
Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks
干预措施: Solifenacin Succinate Tablets (Drug)
Solifenacin Succinate Tablets and Estrogen capsules
Experimental
Solifenacin Succinate Tablets (5mg/d) + local estrogen for 12 weeks
干预措施: Estrogen (Drug)
Solifenacin Succinate Tablets
Active Comparator
Solifenacin Succinate Tablets (5mg/d) for 12 weeks
干预措施: Solifenacin Succinate Tablets (Drug)
结局指标
主要结局
Difference between the mean urination times (24h) at the end of treatment and the baseline value
时间窗: 12 weeks
次要结局
- Difference between the mean urgent micturition times (24h) and the baseline value(on week 12)
研究者
研究点 (1)
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