NCT00210444已完成2 期
A Phase II, Multicentre, Open, Randomised, Parallel Group, Dose Ranging Study to Define the Efficacy of Dysport® in the Treatment of Anal Fissure.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 168
- 试验地点
- 14
- 主要终点
- Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.
研究概览
简要总结
To evaluate the effect on healing rates of two different prognostic factors in patients treated with Dysport® for anal fissure: duration of fissure and dose of study drug
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having idiopathic anal fissure in the posterior anal midline
- •Patients having anal fissure present for less than 6 months
- •Patients having symptoms (pain) present for a minimum of 2 weeks and not responding after 2 weeks of standard therapy (diet, laxatives, sitz-bathes)
排除标准
- •Patients having anal fistulas or anal fissure of various causes such as Crohn disease, Behcet infectious ulceration, anal suppuration, subfissural infiltration, abscesses, acute haemorrhoidal attacks or inflammatory bowel disease
- •Patients having idiopathic anal fissure in the anterior anal midline
- •Patients having lateral or multiple fissures
- •Patients having anal or perianal cancer
- •Patients who underwent previous anal surgery or have cicatricial alterations or post-surgical cicatricial lesions
- •Patients receiving drugs affecting neuromuscular transmission
- •Patients who have received topical anaesthetic within 3 days of injection
- •Patients receiving local treatment by myorelaxing agent
- •Patients receiving prohibited analgesics
- •Patients having bleeding disturbances or currently using coumarin derivates
- •Patients having myasthenia or any genetic muscle disease
结局指标
主要结局
Healing of the anal fissure by complete re-epithelisation of the anal canal mucosa.
次要结局
- Improvement of anal pain measured by the patients on Analogue Visual Pain Scale.
研究者
研究点 (14)
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