NCT00752141已完成1 期
Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers
Watson Pharmaceuticals0 个研究点目标入组 153 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 主要终点
- Measure of accuracy of delayed recall name-phase association test
研究概览
简要总结
The purpose of this study is to explore the possible cognitive effects of oxybutynin tablets and oxybutynin gel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 60 and over
- •English as a primary language
- •Given written informed consent by signing and dating an informed consent form prior to study entry
排除标准
- •Current diseases in which the use of oxybutynin is contraindicated
- •History of narrow-angle glaucoma or urinary or gastric retention
- •Current use of drugs known to effect memory and cognition
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Experimental
oral oxybutynin
干预措施: oxybutynin chloride immediate-release (Drug)
2
Experimental
oxybutynin topical gel
干预措施: oxybutynin chloride topical gel (Drug)
3
Placebo Comparator
placebo tablets plus placebo gel
干预措施: placebo (Other)
结局指标
主要结局
Measure of accuracy of delayed recall name-phase association test
时间窗: one week
次要结局
- Effects on other cognitive domains measured by various tests(one week)
研究者
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