EUCTR2012-002083-27-DE进行中（未招募）不适用
Placebo-controlled double-blind trial investigating the efficacy and tolerability of Posterisan® akut with lidocaine 60 mg/suppository in abatement of complaints associated with hemorrhoids
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- signed informed consent
- •- adults = 18 years
- •- patients with complaints associated with hemorrhoids (pain or burning or itching)
- •- at least one of the symptoms associated with hemorrhoids (pain, burning, itching) hast to be = 65 on the visual analogue scale (VAS): Most bothersome symptom
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Intra-anal or peri-anal thrombosis
- •- hemorroides grade III and IV
- •- known type IV hypersensitivity
- •- diagnosed rectal carcinoma
- •- diagnosed chronic inflammatory bowel diseases (Morbus Crohn, Colitis ulcerosa)
- •- anorectal infection
- •- use of symptoms' relieving medications (e.g. antihistamines, local anesthetics, analgetics), or in the context of any causal treatment, which could influence the symptoms pain, burning or itching, one week before screening
- •- hypersensitivity against lidocaine or any other substance of the investigational product
- •- known or suggested drug or alcohol abuse
- •- pregnancy and lactation
- •- participation on a clinical trial 12 weeks before screening
- •- committal to an institution due to an official or court order
研究者
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