NCT05288907已完成不适用
SOOTHER Trial: Study of an Over-the-Counter Ointment to Treat Rectal Itch
Bell International Laboratories1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Symptom assessment
研究概览
简要总结
Longitudinal, observational, single-arm trial of a novel, composite Lidocaine ointment to treat rectal itch (pruritus ani)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of pruritus ani (anal itch/discomfort) for at least 2 weeks, and a compatible physical exam.
排除标准
- •Inability to understand informed consent, history of inflammatory bowel disease, known venereal disease, or immunodeficiency disease, history of or current anal or perianal abscess, anal or rectal surgery within the past 12 weeks, pregnancy or breastfeeding female, or signs of other rectal diseases such as anorectal fistula, infection, perianal eczema or tumors.
研究组 & 干预措施
Pruritus ani patients
Adult patients with pruritus ani (rectal itch) treated with lidocaine ointment
干预措施: Lidocaine Ointment (Drug)
结局指标
主要结局
Symptom assessment
时间窗: 2 weeks
SOOTHER Symptom assessment at 2 weeks rated on a 5-point analog scale, with 5 being the worst
Visual ano-rectal exam
时间窗: 2 weeks
Visual ano-rectal exam assessment at 2 weeks rated on a 5-point analog scale, with 5 being the worst.
次要结局
未报告次要终点
研究者
研究点 (1)
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