EUCTR2006-003931-63-GB进行中（未招募）不适用
A double-blind, placebo-controlled, randomised, multi-centre, dose-ranging study to determine the safety and efficacy of three concentrations of topical diltiazem cream in the treatment of chronic anal fissure. - Diltiazem cream for chronic anal fissure
S.L.A. Pharma (UK) Ltd0 个研究点目标入组 352 人开始时间: 2007年1月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 352
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
- •For inclusion in the study, subjects must satisfy all of the following criteria:
- •1. Male or female subjects aged = 18 years who have given written, informed consent.
- •2. Symptomatic, chronic anal fissure (pain on or following defecation) present for =4 weeks and presenting with notable fissure-related pain.
- •3. Evidence of circumscribed fissure, with induration at the edges, with or without a sentinel tag.
- •4. Female subjects of childbearing potential must have negative urine pregnancy test on entry and be using adequate contraception.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects for whom any of the following criteria apply are not eligible for inclusion in the study:
- •1. Subject with acute fissure (symptoms of duration <4 weeks, no induration at edges).
- •2. Previous surgical treatment for anal fissure.
- •3. Other previous surgery involving the anal canal or perianal region.
- •4. Score of =30mm at baseline on the Visual Analogue Scale (VAS) for anal pain on defecation and a score of =2 on the Numeric Rating Scale for anal pain on defecation (baseline pain score is the average anal pain on defecation for the 3 defecations prior to randomisation).
- •5. Medical treatment of anal fissure during the past 4 weeks with gyceryl trinitrate cream (GTN cream, Rectogesic) or topical steroid containing creams (e.g. Xyloproct cream, Anusol HC etc.).
- •6. Subjects who have previously failed to respond to topical diltiazem therapy.
- •7. Subjects currently using any drugs which, in the opinion of the investigator, may influence anal sphincter tone or blood supply (e.g. a- or ß-adrenoceptor agonists [other than inhaled ß-agonists] or antagonists, sympathomimetics, anti-hypertensive agents, medical treatments for irritable bowel syndrome, PDE V inhibitors).
- •8. Subjects on antibiotic therapy.
- •9. Subjects with a history of inflammatory bowel disease.
- •10. Subjects with anal fissure associated with other conditions such as HIV infection, fistula-in-ano, perianal sepsis, malignancy or as a result of traumatic childbirth.
- •11. History or evidence on examination of pre-existing cardiac disease, including severe bradycardia, arrhythmias and conduction abnormalities.
- •12. Coexisting gastrointestinal disease or previous gut resection.
- •13. Known hypersensitivity to diltiazem.
- •14. Any mental or other impairment which, in the investigator’s opinion would render them unlikely to be able to comply with the requirements of the study.
- •15. Participation in a clinical trial within the past 3 months.
- •16. Previous participation in the D-CAF-06 trial.
- •17. Concomitant medication acting on the central nervous, cardiovascular (other than low-dose aspirin for prophylaxis) or gastrointestinal system. Xyloproct use is not permitted. Analgesics use is also not permitted during the study, although limited paracetamol use will be permitted.
- •18. Women who are pregnant or breast-feeding.
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