NCT02193139已完成2 期
A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of An Anticholinergic Agent for the Treatment of Primary Axillary Hyperhidrosis
Watson Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2013年12月最近更新:
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
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Gravimetric measurement of sweat production
研究概览
简要总结
This Phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing medication and identify the dose or doses that may effectively reduce axillary sweating in hyperhidrotic subjects. The anticholinergic agent being studied is designated WL8713.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy volunteers with primary axillary hyperhidrosis
- •Poor quality of life rating on the Hyperhidrosis Disease Severity Scale (score of 3 or 4)
- •Has a baseline gravimetric measurement of spontaneous resting sweat production of ≥100 mg/10 min at room at room temperature in at least one axilla
- •Meets at least two of the following criteria (self-reported):
- •sweating is bilateral and symmetrical
- •excessive sweating impairs daily activities
- •subject experiences at least one sweating episode per week
- •excessive sweating onset was earlier than age 25 years
- •has a positive family history for excessive sweating
- •cessation of sweating during sleep
排除标准
- 未提供
研究组 & 干预措施
WL8713, 6 mg
Experimental
6 mg WL8713 administered daily
干预措施: WL8713, 6 mg (Drug)
WL8713, 12 mg
Experimental
12 mg WL8713 administered daily
干预措施: WL8713, 12 mg (Drug)
WL8713, 18 mg
Experimental
18 mg WL8713 administered daily
干预措施: WL8713, 18 mg (Drug)
WL8713, 24 mg
Experimental
24 mg WL8713 administered daily
干预措施: WL8713, 24 mg (Drug)
Placebo
Placebo Comparator
placebo administered daily
干预措施: Placebo (Drug)
结局指标
主要结局
Gravimetric measurement of sweat production
时间窗: 6 weeks
Change from baseline in mean (bilateral average) sweat weight at Week 6 (LOCF)
次要结局
- Global Assessment of Disease State responses(6 weeks)
- Hyperhidrosis Disease Severity Scale (HDSS) scores(6 weeks)
- Dermatology Life Quality Index (DLQI) scores(6 weeks)
研究者
研究点 (1)
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