NCT01421823撤回1 期
A Double Blinded Study to Examine the Effect of Alpha Agonist Ointment on Fecal Incontinence in Patients With Idiopathic Fecal Incontinence
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Fecal Incontinence
研究概览
简要总结
The purpose of this study is to assess the effect and safety of alpha agonist ointment on fecal incontinence severity in patients with idiopathic fecal incontinence.
详细描述
This is a double blinded cross over study. Approximately 40 subjects will be participating in this 4 weeks study. A screening visit will be used to determine eligibility for the study. Patients found eligible will receive alpha agonist ointment or placebo ointment for 2 weeks. This will be followed by a second 2 weeks treatment cycle in which:
- patients previously treated with alpha agonist will be treated with placebo.
- patients previously treated with placebo will be treated with alpha agonist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent.
- •Male or female subjects 18 to 65 years of age.
- •Fecal incontinence score over
- •The patient is able to understand the treatment and is willing to comply with the prescribed regimen.
排除标准
- •Has a clinically significant history or presence of any of the following conditions:
- •Known allergy to the API.
- •Porphyria.
- •Glaucoma.
- •Pregnancy or lactation.
- •Active or past history of cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities;
- •Type 1 diabetes mellitus;
- •Insulin treated type 2 diabetes mellitus.
- •Renal insufficiency.
- •Liver insufficiency.
- •Malignant disease within 5 years of screening;
- •Has hypertension (sitting blood pressure over 140/90 mmHg at screening)
- •History of rectal surgery.
- •History of HIV, hepatitis B, hepatitis.
- •Has used, in the last four weeks, drugs that may affect blood coagulation, such as Aspirin (at a dose above 250 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
- •Use of tricyclic or monoamine-oxidase inhibitors.
- •Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
- •Unable to understand the use instruction for the ointment, as judged by the investigator.
研究组 & 干预措施
alpha agonist ointment
Experimental
干预措施: alpha agonist ointment (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Fecal Incontinence
时间窗: After 2 weeks of treatment
number of unwanted/unexpected bowel movements in the time period after use of alpha agonist ointment
次要结局
未报告次要终点
研究者
研究点 (1)
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