EUCTR2006-002494-48-GB进行中（未招募）不适用
Sildenafil in Crohn’s disease: an open label pilot study of Sildenafil in 15 patients with active colonic Crohn’s disease - Sildenafil in active colonic Crohn’s disease
niversity College London / University College London Hospitals NHS Foundation Trust0 个研究点目标入组 15 人开始时间: 2006年9月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
- •1) Able to give informed consent
- •2) Definite diagnosis of colonic Crohn's disease based on radiological, endoscopic and/or histological criteria
- •3) Moderate-to-severe disease activity, defined as a Crohn's Disease Activity Index (CDAI) score of 220?475
- •4) Patients on no medication, or having received stable doses of antibiotics, aminosalicylates or nutritional supplements for at least 4 weeks
- •5) Patients on immunosuppressants (except steroids) must have received a stable dose for at least three months
- •6) 18 years of age or older
- •7) Able to comply with trial requirements (drug taking and visits)
- •8) Negative serum pregnancy test in females of child-bearing potential, who must agree to use an adequate method of contraception for the duration of trial
- •9) Stool sample negative for pathogenic bacteria, ova and/or parasites, and C. difficile toxin
- •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
- •1) Use of steroids within four weeks or infliximab within eight weeks of start of trial medication; use of any trial medication within the preceding 3 months
- •2) Existing colostomy or ileostomy; current symptoms of bowel obstruction; any other severe concurrent morbidity including bleeding disorders or active upper gastrointestinal peptic ulceration; likely need for hospitalisation during the period of the study
- •3) Recent stroke or myocardial infarction (within the preceding 6 months), unstable angina pectoris, moderate or severe cardiac failure, uncontrolled arrhythmias, uncontrolled hypertension, QT3 prolongation on ECG, any patient with hypotension or in whom vasodilation is clinically inadvisable
- •4) Significant hepatic or renal dysfunction (ALT > twice ULN; creatinine > 149 micromol/L)
- •5) Current use of any phosphodiesterase-5 inhibitor
- •6) Current use of CYP 3A4 inhibitors (e.g. erythromycin, saquanavir, ketoconazole, itraconazole)
- •7) Current use of organic nitrates or organic nitrites in any form (e.g. glyceryl trinitrate, isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil)
- •8) Alpha-blocker therapy, unless stable dose for at least 1 month
- •9) Prior episode non-arteritic anterior ischaemic optic neuropathy
- •10) Previous adverse reaction to any phosphodiesterase-5 inhibitor
- •11) Women who are currently or attempting to become pregnant, or those who are breast-feeding
- •12) Male patients with anatomical deformation of the penis or predisposition to prolonged erection
研究者
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