NCT01483833已完成2 期
Protocol for the Study of the Effects of S-MPEC (Iferanserin) in Patients With Hemorrhoids
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Assessment of hemorrhoid bleeding
研究概览
简要总结
To evaluate the safety and efficacy of topical 0.5% S-MPEC cream vs. placebo cream (applied twice daily for 14 days) in the treatment of Grade I - III hemorrhoids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Diagnosis of grade I - III hemorrhoids with bleeding episodes of at least every other day during the last two weeks before enrollment in the study.
- •Patients signing the Informed Consent form.
排除标准
- •Patients with protruding or irreducible hemorrhoids (grade IV).
- •Patients with anal fistulas, periproctitis or hemorrhagic diathesis
- •Patients with current history of Type I or Type II diabetes mellitus.
- •Patients with severe hepatic, renal or cardiovascular disorders.
- •Patients with any type of infectious disease.
- •Patients who have been involved with another experimental drug trial within the past 30 days.
- •Patients presently diagnosed with cancer.
- •Patients who have known alcohol and drug abuse.
- •Patients who require the use of suppositories.
- •Patients with blood or urine laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator.
研究组 & 干预措施
Iferanserin
Active Comparator
Iferanserin administration intra-anally twice daily for 14 days
干预措施: Iferanserin (Drug)
Placebo
Placebo Comparator
Placebo administration intra-anally twice daily for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of hemorrhoid bleeding
时间窗: Day 7 and 14
Change from pre-treatment in patient assessment of hemorrhoid bleeding (10-point scale: 1=Not at all, 10=Extremely) at the end of one- and two-weeks of treatment are the primary efficacy endpoints for the study.
次要结局
- Assessment of bleeding, hemorrhoid size, other hemorrhoid symptoms, and physician evaluation of hemorrhoids.(14 days)
研究者
研究点 (1)
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