NCT00910832已完成4 期
Comparative, Randomized, Double-blind Study of the Efficacy of Eductyl® Versus Placebo for Treatment of Patients With Dyschesia Treated by Rectal Rehabilitation
Laboratoires Techni Pharma1 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2009年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation on VAS of intensity of symptoms
研究概览
简要总结
The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation.
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
- •Male or female over 18 years
- •Patients with dyschesia
- •Prescription of rehabilitation for dyschesia
排除标准
- •Rectal diseases
- •Pain killers
- •Pregnant women
- •Breast feeding patients
- •Non-compliant patients
研究组 & 干预措施
Eductyl suppository
Experimental
干预措施: Eductyl suppository (Drug)
Placebo suppository
Placebo Comparator
干预措施: Placebo suppository (Drug)
结局指标
主要结局
To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation on VAS of intensity of symptoms
时间窗: Day -7, 0, 3, 7, 10, 14, 17, and 21
次要结局
- To assess the efficacy on change symptoms and safety of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation(Day 0 and 21)
研究者
研究点 (1)
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