NCT02299557已完成1 期
A Double Blind Study to Examine the Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application.
研究概览
简要总结
This is an double blinded, cross-over study to determine the effect of Oxymetazoline gel on anal resting pressure and fecal incontinence in patients with spinal cord injury. Approximately 17 subjects are expected to complete this 10 weeks study that will include two treatment periods of 4 weeks each, and one 2 weeks wash out 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 Injury that occurred at least 3 months from randomization day and less than 3 years from randomization day.
- •At least 4 unwanted/unexpected incontinent events/week
排除标准
- •Known allergy to Oxymetazoline or silicone.
- •Pregnancy or lactation.
- •Active 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;
- •History of rectal surgery.
- •History of HIV, hepatitis B, hepatitis C.
- •Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion.
- •Has used, in the last 1 week, drugs that may affect blood coagulation, such as Aspirin (at a dose above 500 mg/day), Warfarin, Sintrom, Enoxaparin, Nadroparin, Heparin, Clopidogrel, Ticlopidine.
- •Hypertension (blood pressure over 150/105 mm Hg in screening visit)
- •Unable to understand the use instruction, as judged by the investigator.
研究组 & 干预措施
Treatment
Experimental
Intra-anal Oxymetazoline gel once daily
干预措施: Oxymetazoline gel (Drug)
Placebo
Placebo Comparator
Intra-anal Placebo gel once daily
干预措施: Placebo gel (Drug)
结局指标
主要结局
To examine the effect of Oxymetazoline gel on fecal incontinence episodes in the 8 hours following application.
时间窗: 4 weeks
次要结局
- Number of participants with adverse events(4 weeks)
- Pharmacokinetics (area under the curve [AUC]), peak concentration and half life time (T 1/2) of Oxymetazoline;(4 weeks)
研究者
研究点 (1)
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