EUCTR2006-002739-25-GB进行中（未招募）1 期
A double-blind, randomised, placebo-controlled study to evaluate topical 10%phenylephrine gel applied peri-anally in the management of ileal pouch anal anastomosis (IPAA)-related faecal incontinence - A study to Evaluate 10% Phenylephrine Gel in the Management of Faecal Incontinence
S.L.A. Pharma (UK) Ltd0 个研究点目标入组 100 人开始时间: 2012年2月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •A subject will be considered eligible for this study only if all of the following criteria apply:
- •Incontinence of solid or liquid stool/mucus following ileo-anal pouch construction, at least once per week over the last month
- •At least six months must have elapsed since IPAA surgery or six months since closure of a loop ileostomy created during IPAA surgery, whichever is the later
- •Aged 18 years or over
- •If female, the subject must not be lactating and must be (a) post-menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use adequate contraception for the duration of the study
- •Written informed consent to participate has been provided
- •NB: Seepage, leakage, soiling of faecal material is regarded as incontinence.
- •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
- •A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- •A history of surgery to the anal sphincter complex
- •Active pouchitis (determined by clinical examination and macroscopic inflammation on endoscopy. Patients on maintenance antibiotics need not be excluded but their antibiotic dose should remain the same throughout the study)
- •Undergone pelvic radiotherapy at any time
- •Cardiac or cardiovascular disease, including ischaemic heart disease, history of stroke, cerebral arteriosclerosis, aneurysm, tachycardia or hypertension
- •Hyperthyroidism or diabetes mellitus
- •Crohn’s disease (indeterminate colitis is not an exclusion criterion)
- •The use of a- or ß-adrenoceptor agonists (other than inhaled ß-adrenoceptor agonists) or antagonists, other sympathomimetics or any cardiovascular drugs during the study (including eyedrops, nasal drops and OTC cold cures containing phenylephrine or pseudoephedrine)
- •The use of mono-amine oxidase inhibitors or tricyclic antidepressants in the 4 weeks prior to the first dose of study medication or during the study
- •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
- •Considered by their physician unlikely to be able to comply with the protocol
- •Participation in a clinical trial within the past three months
- •Known hypersensitivity to phenylephrine or excipients
- •History of drug or alcohol abuse
研究者
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