NCT01855256已完成3 期
Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Evaluation of the effectiveness of oxybutynin in hyperhidrosis
研究概览
简要总结
Evaluation of the effectiveness of oxybutynin in hyperhidrosis
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years
- •Patient affiliated to social security or beneficiary of such a regime
- •Patient able to consent
- •Patient with hyperhidrosis, generalized or localized (palmar, plantar, axillary) and whose score HDSS (Hyperidrosis Disease Severity Scale) is greater than two.
排除标准
- •Age less than 18 years
- •Patient who can't be followed
- •Patient participating in another clinical trial
- •Woman breastfeeding
- •Hypersensitivity to oxybutynin or any of the excipients
- •Risk of urinary retention related disorders uretroprostatiques
- •Intestinal obstruction
- •Toxic megacolon
- •Intestinal atony
- •Severe Ulcerative Colitis
- •Myasthenia
- •Closure glaucoma the anterior chamber angle or slightly deep
研究组 & 干预措施
oxybutynin
Experimental
Oxybutynin was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks.
干预措施: Oxybutynin (Drug)
Placebo
Placebo Comparator
Placebo was done at 2.5 mg/day from day 1 to day 4, then at 5 mg/day from day 5 to day 7 and at 7.5 mg/day from day 8 to the end of the 6 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of the effectiveness of oxybutynin in hyperhidrosis
时间窗: 6 weeks
Two scales are used for this evaluation (Hyperhydrosis Disease Severity Scale and Dermatology Life Quality Index )
次要结局
- Safety evaluation of treatment in this indication(6 weeks)
研究者
研究点 (4)
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