NCT00153114已完成4 期
PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children
Braintree Laboratories3 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2003年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Greater than 2 bowel movements per week
研究概览
简要总结
Assess the safety and efficacy of polyethyleneglycol3350 laxative as compared to placebo therapy in pediatric patients with a history of constipation.
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
- Double
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients between the ages of 4 to 16 years.
- •Adolescent female patients must not be pregnant or lactating.
- •constipated according to ROME I definition
- •Two or fewer bowel movements during the initial observation week.
- •Absence of a stool impaction
- •Bowel movement after receiving enema
- •Are otherwise in good health, as judged by a physical examination.
- •Parent or guardian is mentally competent to sign an instrument of informed consent
排除标准
- •Patients with heme positive stool at baseline exam.
- •Patients with fecal impaction at baseline, or after the observation period, as indicated by physical exam
- •Patients with known or suspected perforation or obstruction other than fecal impaction.
- •Patients who are breastfeeding, pregnant or intend to become pregnant during the study.
- •Female patients of childbearing potential who refuse a pregnancy test.
- •Patients with a known history of organic cause for their constipation.
- •Patients with congenital malformations that produce constipation (Hirschsprung's disease, imperforate anus, children with cerebral palsy or other neurologic abnormalities, or systemic diseases).
- •History of gastric retention, inflammatory bowel disease, bowel resection, or colostomy.
- •Use of concomitant medications that cause constipation
- •Patients who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures.
- •Patients with known allergy to polyethyleneglycol or polyethyleneglycol containing medications.
- •Patients with clinically significant elevations of TSH or abnormal plasma electrolytes.
- •Patients who, within the past 30 days have participated in an investigational clinical study
结局指标
主要结局
Greater than 2 bowel movements per week
次要结局
- Analysis of individual ROME I criteria
- Safety (adverse event and laboratory testing)
研究者
研究点 (3)
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