A Multicenter, 6-month, Open-label Safety Study of Lubiprostone in Pediatric 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
- 87
- 试验地点
- 13
- 主要终点
- Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
A study of the safety of lubiprostone in pediatric participants aged ≥ 6 Years to < 18 years diagnosed with functional constipation.
详细描述
To assess the long-term safety and tolerability of oral lubiprostone 12 or 24mcg capsules dosed twice daily (BID) when administered orally for 24 weeks in pediatric participants with functional constipation. Evaluation of lubiprostone safety and tolerability is the primary objective in this study.
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
- •Medically-confirmed diagnosis of Functional Constipation per Rome III Diagnostic Criteria for Childhood Functional Constipation
- •At least 6 years of age but less than 18 years of age at the time of randomisation
- •Only stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors are allowed if participant is taking antidepressants
排除标准
- •Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation
- •Untreated faecal impaction at the time of screening
- •Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication
研究组 & 干预措施
Lubiprostone
Participants received lubiprostone twice daily (BID). Participants received either lubiprostone 12 mcg BID, lubiprostone 24 mcg BID (dose based on participant's weight) up to 24 weeks.
干预措施: Lubiprostone (Drug)
结局指标
主要结局
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
时间窗: within 25 weeks
Adverse events with onset dates after the administration of the first dose of study medication or prior to the last day of treatment plus 7 days are considered treatment-emergent.
次要结局
未报告次要终点