NCT01243723已完成4 期
Étude Comparative, randomisée, Double-insu, en Groupes parallèles évaluant l'efficacité d'Eductyl® Versus Placebo Chez Des Patients Souffrant d'Une dyschésie
Laboratoires Techni Pharma1 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2010年11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 on VAS of intensity of inconfort
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.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged from 18 to 75 years old,
- •Writing consent to take part in the study,
- •Patient with a dyschesia according to Rome III criteria
- •An intensity of the inconfort using a VAS (0 (no inconfort) to 100 mm (maximal and no supportable inconfort)) equal or over 40 mm
排除标准
- •Patient suffering of neurologic affection,
- •Rectal diseases including :
- •Current anal ou peri-anal pain,
- •Current organic injury of colon or rectum,
- •Current anal injury,
- •Current rectal Prolapse,
- •Current haemorrhoid,
- •Colon inflammatory disease (ulcero haemorrhagic recto colitis, Crohn disease...),
- •Current ano-recto-colon stenosis (anastomosis, scarring ...)
- •Patient undergone pain killers (WHO level II (except dextropropoxyphen) and III) during the last 8 days,
- •Patient undergone anti-depressants except if this treatment is regular for at least 15 days and it won't be modified during the study,
- •Patient with a constipation treatment except if this treatment is regular for at least 15 days and it won't be modified during the study
- •Intolerance to Eductyl® or to one of its components (potassium tartarate acid, sodium bicarbonate, solid hemisynthethic glycerides, soya lecithin, talc)
- •Use of Eductyl® during the previous 15 days (over 5 days in the last 15 days),
- •Patient already included in clinical trial in the last month,
- •Pregnant or breast feeding woman,
- •Woman of childbearing potential without contraception,
- •Patient unable to read and write.
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 on VAS of intensity of inconfort
时间窗: Day 0 and day 21
次要结局
- To assess the intensity of inconfort of patients with dyschesia on Likert scale(Every day from day 0 to day 21)
- To assess the efficacy of Eductyl versus placebo on dyschesia related quality of life(Day 0 and day 21)
- To assess the efficacy of Eductyl versus placebo on bowel function index(Day 0 and day 21)
- To assess the efficacy of Eductyl versus placebo on global impression of change(Day 21)
- To assess the tolerance of Eductyl versus placebo(Day 21)
研究者
研究点 (1)
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