NCT01297608撤回2 期
A Double Blinded Study to Examine the Effect of Coated Suppositories on Fecal Incontinence in Patients With Spinal Cord Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- fecal incontinence
研究概览
简要总结
This is a double blinded cross over study. Approximately 20 spinal cord injury patients will be participating in this 4 weeks study.The primary outcome is difference in fecal incontinence as recorded in diaries, between the treatment period and the treatment period.
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 55 Years（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 55 years of age; Spinal cord lesion/disease/injury at any level at least 3 months from injury. FISI (Fecal Incontinence Severity Index) > 8 units. The patient is able to understand the treatment and is willing to comply with the prescribed regimen
排除标准
- •Known allergy to experimental drug..
- •Porphiria.
- •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 > 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 inhibors.
- •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 coated suppository, as judged by the investigator.
研究组 & 干预措施
treatment
Experimental
干预措施: caoted suppository (Drug)
treatment
Experimental
干预措施: coated suppository (Drug)
placebo
Placebo Comparator
干预措施: coated suppository (Drug)
结局指标
主要结局
fecal incontinence
时间窗: 2 weeks
次要结局
- quality of life(2 weeks)
研究者
研究点 (1)
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