A Single Centre Study to Assess the Safety and Efficacy of Movicol in the Treatment of Faecal Impaction in Children Followed by a Double Blind, Randomised Phase to Compare the Safety and Efficacy of Movicol and Lactulose for Maintenance Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children.
研究概览
简要总结
This was a single centre study comprised of two stages (Parts I and II). Part I was a 9-day open label evaluation of Movicol administered to patients in hospital. This study evaluated the safety and efficacy of Movicol in treating faecal impaction. Movicol was administered over 3 - 7 days to achieve disimpaction.
详细描述
Patients received Movicol treatment until disimpaction was achieved according to the following regime:
Day 1: Ages 2 - 4 received 1 (one) sachet whilst 5 - 11 year olds received 2 (two).
Day 2: Ages 2 - 4 received 2 (two) sachets whilst 5 - 11 year olds received 3 (three).
Day 3: Ages 2 - 4 received 2 (two) sachets whilst 5 - 11 year olds received 4 (four).
Day 4: Ages 2 - 4 received 3 *three) sachets whilst 5 - 11 year olds received 5 (five).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients that, in the opinion of the investigator, are constipated/fecally impacted as to require hospital stay to treat and/or relieve the impaction
- •children aged 2 - 11 years old inclusive
- •patients of either sex
排除标准
- •Patients with
- •intestinal perforation or obstruction
- •severe inflammatory conditions of the intestinal tract
- •uncontrolled renal/hepatic/cardiac diseases
- •uncontrolled endocrine disorder(s)
- •any neuromuscular condition affecting bowel function
- •hypersensitivity to lactulose or PEG or other constituent of Movicol
- •patients who have taken any investigational drug in the three months
- •patients or patients whose parents would in the opinion of the investigator are unable to comply with requirements of the study
结局指标
主要结局
evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children.
次要结局
未报告次要终点