A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 140
- 主要终点
- Number of Participants Classified as Treatment Responders Within 12 Weeks
研究概览
简要总结
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.
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
Care provider and outcomes assessor were also blinded for this double-blind trial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient can be considered for eligibility to participate if he/she:
- •Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening
- •Is diagnosed with OBD
- •Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs)
- •Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study
排除标准
- •A patient cannot be considered for eligibility to participate if he/she:
- •Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction
研究组 & 干预措施
Lubiprostone
24 mcg capsules twice daily (BID)
干预措施: Lubiprostone (Drug)
Placebo
0 mcg capsules twice daily (BID)
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Classified as Treatment Responders Within 12 Weeks
时间窗: 12 weeks
Spontaneous bowel movement (SBM) is defined as any BM that does not occur within 24 hours after use of rescue medication. To be classified as responders, participants are required to demonstrate at least moderate response (≥ 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data are available, and must additionally demonstrate a full response (≥ 3 SBMs per week) for at least 9 of the 12 treatment weeks.
次要结局
- Number of SBMs Per Week at Week 12(at Week 12)
- Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation(within 48 hours post-dose)
- Number of SBMs Per Week Overall(within 14 weeks)
- Number of SBMs Per Week at Week 8(at Week 8)