临床试验/NCT00255372

NCT00255372已完成3 期

Polyethylene Glycol Laxative (Macrogol 4000;Forlax®) for Treatment of Chronic Constipation in Children : A Phase III, Bicentric, Randomized, Double-blind, Lactulose Controlled Study.

Ipsen2 个研究点分布在 1 个国家目标入组 88 人开始时间: 2005年4月最近更新: 2020年4月24日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Ipsen
入组人数: 88
试验地点: 2
主要终点: Bowel movement frequency

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether Forlax® is more effective than placebo in relieving chronic constipation in children who may also suffer from soiling or faecal incontinence.

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: Double (Participant, Investigator)

入排标准

年龄范围: 12 Months 至 36 Months（Child）
性别: All
接受健康志愿者: 否

入选标准

•Chronic constipation (defined as at least 3 months of less than 2 bowel movements (BMs) per week and/or one of the following symptoms : hard stool, painful defecation, encopresis)
•Constipation previously treated by dietary advice (high fiber diet) for at least two weeks without efficacy

排除标准

•Organic bowel diseases
•Suspected GI obstruction
•History of GI surgery

研究组 & 干预措施

2

Active Comparator

干预措施: Lactulose active and Lactulose placebo (Drug)

1

Experimental

干预措施: PEG 4000 (Forlax®) (Drug)

结局指标

主要结局

Bowel movement frequency

时间窗: week 4

次要结局

Subjective symptoms associated with defecation.(At every visit)

研究者

发起方

Ipsen

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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