Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children. A Controlled Double Blind Randomized Study vs a Standard PEG-EL Laxative
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 主要终点
- Efficacy
研究概览
简要总结
The aim of this study is to compare the efficacy, tolerability, acceptance and compliance of a PEG-only formulation compared to a reference PEG-EL formulation in resolving faecal impaction and in the treatment of chronic constipation
详细描述
Constipation is a very common complaint in childhood. Inadequate daily fiber intake, insufficient fluid intake, and withholding behavior are considered as factors leading to constipation.
Painful defecation is considered a common trigger to faecal retention wich leads to reabsorption of fluids and increase in the size and consistency of stools.
It is often necessary to use laxative therapy to achieve comfortable defecation. PEG-based laxatives are considered today the gold standard for treatment of constipation in children. PEG formulations differ for composition in inactive ingredients which may have an impact on acceptance, compliance and adherence to treatment.
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
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •out-patients children with diagnosis of functional constipation or have faecal impaction on medical history and physical examination
排除标准
- •children with organic causes for defecation disorders, such as Hirschsprung disease, spina bifid, hypothyroidism, or other metabolic or renal abnormalities;
- •Children receiving medication influencing gastrointestinal motility;
- •Children with suspected gastrointestinal obstruction or stenosis
研究组 & 干预措施
PEG-only
Polyethylene glycol 4000 only (PEG-only).
干预措施: Polyethylene glycol (Device)
PEG-EL
Polyethylene glycol 3350 with electrolytes (PEG-EL).
干预措施: Polyethylene glycol with electrolytes (Drug)
结局指标
主要结局
Efficacy
时间窗: 7 days
Feacal impaction resolution
次要结局
- Acceptability(4 weeks of observation)
- Efficacy(4 weeks)
- Clinical tolerability(4 weeks of observation)
- Compliance(4 weeks)
研究者
Giovanni Di Nardo
MD
Azienda Policlinico Umberto I