An Open-label Study Assessing Long-term Safety of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 564
- 试验地点
- 48
- 主要终点
- Long-term Safety Assessed Through Adverse Events and Local Skin Reactions
研究概览
简要总结
This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.
详细描述
Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance
- •Male or females
排除标准
- •Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated
- •Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy
- •Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for participation in the study
研究组 & 干预措施
Glycopyrronium
Glycopyrronium Topical Wipes
干预措施: Glycopyrronium Topical Wipes (Drug)
结局指标
主要结局
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions
时间窗: Day 1 - Week 44
The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.
次要结局
未报告次要终点