A Multicentre, Long-term Safety, Efficacy, and Pharmacokinetics Study of Lubiprostone in Paediatric Subjects Aged ≥ 6 Years to < 18 Years With Functional Constipation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 85
- 主要终点
- Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month
研究概览
简要总结
This study is for children with constipation.
Children who completed 3 months of treatment in the earlier study (NCT02042183):
- were invited to participate
- will receive lubiprostone for 9 more months
- will see if lubiprostone safely relieves their constipation if taken for a whole year
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has completed the 3-month placebo-controlled study (NCT02042183)
- •Will continue to abstain from taking concomitant medication (prescribed or over-the-counter) that affects gastrointestinal motility
排除标准
- •Has untreated faecal impaction at the time of rolling over into study
- •Has significant change in medical status, newly diagnosed and uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other systemic disease
- •Has demonstrated non-compliance with study protocol during the 3-month placebo-controlled study (NCT02042183)
研究组 & 干预措施
Lubiprostone
Participants receive lubiprostone twice daily
Participants must have completed the entire 12-week treatment period during the preceding study. Those who received 12 mcg twice daily (BID) continued to receive 12 mcg, those who received 24 mcg BID continued with that dose.Those of the placebo arm in the previous study weighing less than 50 kg received 12 mcg BID and over 50 kg received 24 mcg BID during this study.
干预措施: Lubiprostone (Drug)
结局指标
主要结局
Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month
时间窗: within 9 months
Spontaneous bowel movements are defined as bowel movements without the aid of drugs.
次要结局
未报告次要终点