A Multicentre, Randomised, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics 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
- 606
- 试验地点
- 116
- 主要终点
- Number of Participants Classified as Overall Responders at Week 12
研究概览
简要总结
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.
详细描述
Dose administration details:
- Participants with a body weight <50 kg at baseline received Lubiprostone 12 mcg BID for 12 weeks. If the dose was safe but did not show any efficacy at Week 1, dosage was increased to 24 mcg BID.
- Participants with a body weight >50 kg at baseline received Lubiprostone 24 mcg BID for 12 weeks. If the dose was unsafe at Week 1, dosage was decreased to 12 mcg BID.
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 (Participant, Investigator)
盲法说明
While the care provider and outcomes assessor were also blinded, this was classified as a double-blind trial
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 subject is taking antidepressants
排除标准
- •Any gastrointestinal (GI) condition, other than constipation and/or irritable bowel syndrome (IBS), 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 receive lubiprostone twice daily (BID) up to 12 weeks
干预措施: Lubiprostone (Drug)
Placebo
Participants receive placebo BID up to 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Classified as Overall Responders at Week 12
时间窗: at Week 12
An overall responder is defined as a participant who qualified as a weekly responder for 9 of the 12 treatment weeks, with durability demonstrated by at least 3 of the responder weeks occurring during the last 4 weeks of the treatment period. A weekly responder is defined as a participant who has at least 3 spontaneous bowel movements during the week, and at least one more than at baseline.
次要结局
- Mean Number of SBMs Observed Each Week for 12 Weeks(within 12 Weeks)