EUCTR2017-001216-11-ES进行中（未招募）1 期
sefulness of botulinum toxin type A in the treatment of chronic anal fissure
Dra. A. Teresa Calderón Duque0 个研究点开始时间: 2017年4月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •* Patients seen in the clinical Surgery Consultation with diagnosis of chronic anal fissure.
- •* Patients older than 18 years of age with a diagnostic of fissure of more than two months of evolution who have not responded to previous anal fissure medical treatments. Medical treatment would consist of hygienic dietary measures and systemic and local analgesic treatment with ointments (Annex 1). These ointments will be either calcium antagonists (Diltiazem 2%) or nitrates (Rectogesic 0.4%), whose main function is to relax the smooth muscle of the anus. This treatment should be prescribed for 6-8 weeks before assessing whether or not there has been healing or improvement
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •*Patients with diagnosis of chronic anal fissure that it isn’t idiopathic.
- •* Patients who have not previously received medical treatment for the anal fissure.
- •* Patients with contraindication to the use of Botulinum Toxin type A: Myasthenia gravis, Eaton-Lambert syndrome, pregnant women, acelticoline deficiency.
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