A Phase III Multi-Centre Placebo-Controlled Crossover Study Followed by an Open Label Post-Study Follow-up to Examine the Efficacy and Safety of Movicol in the Treatment of Chronic Constipation in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Mean number of complete defaecations per week in each treatment period
研究概览
简要总结
A phase III, multi-centre, double blind, placebo controlled, crossover study, followed by an open label post study follow-up, to assess the efficacy and safety of Movicol in the treatment of chronic constipation in children
详细描述
After a baseline period of 1 (one) week, subjects who had met the inclusion criteria were entered into the treatment phase of the study. Patients were randomised to receive either Movicol or matching Placebo for two (2) weeks. Following the treatment phase, patients underwent a two (2)-week placebo washout period prior to crossing over to receive the alternative treatment e.g. those patients who took Movicol were given the matching Placebo or vice versa on completion of the washout period for two (2) weeks.
On completion of the double blind treatment phase, patients were given the option to participate in the eight (8) week open label post study follow-up. Patients who participated in the post study follow-up received Movicol.
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
- 24 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients of any ethnic origin will be eligible to participate in the study if all of the following criteria are fulfilled.
- •informed consent having been obtained from the patient's parent or guardian and assent from the child if they are capable of understanding the study
- •aged 24 months - 11 years
- •experiencing constipation as defined as:
- •≤2 complete bowel movements per week, and at least one of the following:
- •pain on defaecation on ≥1 in 4 days
- •1/4 or more of bowel movements with straining
- •1/4 or more of bowel movements with hard or lumpy stools
- •patients in whom these symptoms have been present for ≥3 months
- •available to complete the study and able to comply with requirements and restrictions listed in the patient's/parent's information documents.
排除标准
- •Patients will not be eligible to participate in the study if any of the following conditions apply:
- •faecal impaction or history of faecal impaction
- •history of intestinal perforation or constipation
- •paralytic ileus
- •toxic megacolon
- •Hirschsprungs disease
- •severe inflammatory conditions of the intestinal tract
- •severe gastro-oesophageal reflux - that which is complicated by anaemia, haematemesis, respiratory aspiration, failure to thrive or other recognised complications of gastro-oesophageal reflux
- •patients currently receiving over 0.5mg/kg/day of senna or over 1/2 sachet of sodium picosulphate per day for children <6 years and over 1 sachet sodium picosulphate per day for children > 6 years (i.e. high doses of stimulant laxatives)
- •any other significant medical condition that in the investigator's opinion would effect their suitability for entry into the study
- •patients who have previously received Movicol or previously participated in the study
- •known hypersensitivity to polyethylene (PEG) 3350 or any of the constituents of Movicol
- •patients with diabetes as the placebo to be used in this study is sucrose
- •patients who have received any investigational drug in the last 3 months
- •patients and/or parents who the investigator thinks could not comply with the requirements of the protocol for any reason (particularly in relation to reliable completion of diary cards)
结局指标
主要结局
Mean number of complete defaecations per week in each treatment period
次要结局
- Mean total number of defaecations (complete plus incomplete) per week in each treatment period
- Pain on defaecation
- Straining on defaecation
- Abdominal pain
- Faecal incontinence
- Stool consistency