An Open Single Centre Study To Assess the Safety and Efficacy 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
- 81
- 试验地点
- 1
- 主要终点
- The average number of spontaneous complete defaecations per week recorded over the period of treatment between scheduled visits.
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of Movicol in the treatment of chronic constipation in children.
详细描述
This was a phase III, open, single centre, non-comparative study. All patients were assigned to treatment with Movicol for a period of 12 weeks.
All patients were screened at Day 0 (Visit 1) when baseline assessment of their bowel movements over the previous 14 days were made. Patients were dispensed with Movicol to commence treatment on the following day (Day 1). During the first 5 days the dose was increased on an every second day basis until normal bowel movement was achieved. Thereafter until the end of the study the dosage was titrated according to the stool consistency (diarrhoea, loose stool, hard stools or no bowel movement for 2 days, respectively).
Four on-treatment visits were performed on Day 14 (Visit 2), Day 28 (Visit 3), Day 56 (Visit 4) and Day 84 (Visit 5). At each visit bowel movements over the previous period were assessed by the investigator using the patient's daily diary card data.
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
- 24 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged 24 months - 11 years old inclusive
- •patients with constipation defined as:
- •≤ 2 spontaneous complete bowel movements per week (over the previous 14 days), and one or more of the following:
- •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
- •new patients or those whose management is unsatisfactory on current laxative treatment
- •patients of either sex
- •patients of any ethnic origin
- •hospital in-patients or outpatients.
排除标准
- •Patients with:
- •history of bowel washout within the last 2 months
- •intestinal perforation or history of obstruction
- •recent history of urinary tract infection (within last month)
- •Hirschsprungs disease
- •paralytic ileus
- •toxic megacolon
- •severe inflammatory conditions of the intestinal tract
- •clinically uncontrolled renal/hepatic/cardiac disease(s)
- •clinically uncontrolled endocrine disorder(s)
- •any other severe unstable co-existing disease
- •hypersensitivity to macrogol or other constituents of Movicol
- •encopresis
- •patients who have taken any investigational drug in the last three months
- •patients or patients whose parents would in the opinion of the investigator be unable to comply with the requirements of the study.
研究组 & 干预措施
1
Ages 2 - 6: Day 1= 1 sachet/day; Day 3= 1 sachet BID; Day 5= 1 sachet TID Ages 7 - 11: Day 1= 1 sachet BID; Days 3 & 5 = 2 sachets BID;
干预措施: Polyethylene glycol 3350 Na bicarbonate NaCl KCl (Drug)
结局指标
主要结局
The average number of spontaneous complete defaecations per week recorded over the period of treatment between scheduled visits.
次要结局
- pain on defaecation
- straining on defaecation
- stool withholding
- faecal incontinence (soiling)
- faecal form (Bristol stool scale)
- rectal bleeding
- Assessment of
- abdominal pain
- amount of stool
- efficacy (investigator and parental assessment)
- concomitant laxative treatment