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
- compare the safety and efficacy of Movicol and Lactulose Dry as maintenance therapy.
研究概览
简要总结
This was a single centre study comprised of two stages (Parts I and II). Part II was a 12 week randomised double blind comparison of Movicol and Lactulose Dry as maintenance therapy on an out-patient basis. The aim was to evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children
详细描述
Two days following disimpaction (Part I of the clinical trial) patients were assigned (based on their randomisation number) to receive either Movicol or Lactulose as maintenance therapy for the remainder of the study. At discharge all patients received the appropriate supply of study medication. This includes 1 week's overage should they miss their next visit to the ProMotion clinic. They did not know whether they have been randomised to receive Movicol or Lactulose Dry.
Following discharge patients were contacted after 3-5 days by telephone or home visit (whichever was appropriate) to encourage treatment and to ensure compliance. Parents were instructed to contact the Pro-Motion team who would advise appropriately if patients had any difficulty i.e. none, irregular and/ or uncomfortable or very loose bowel movements.
The daily use of Movicol or Lactulose Dry during Part II was recorded in the diary. If the dose of Movicol or Lactulose was changed by the Pro-Motion team at any time then it was documented appropriately in the patient notes and the case report form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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/faecally 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
compare the safety and efficacy of Movicol and Lactulose Dry as maintenance therapy.
次要结局
未报告次要终点