NCT00620061已完成3 期
A Multi-center, Open-labeled Study of the Long-term Safety and Efficacy of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 119
- 主要终点
- Mean Weekly Bowel Movements (BMs) Per Month
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428
- •Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study
- •Willing to continue to abstain from use of disallowed medications as defined per protocol
排除标准
- •Has newly diagnosed impaired renal function identified at the Screening Visit [i.e., serum creatinine concentration > 1.8 milligrams per deciliter (mg/dL)]
- •Has experienced an unexplained and/or clinically significant weight loss defined as > 5% within 90 days prior to Screening Visit.
- •Has plans to participate in another trial with an investigational drug or device during the course of the extension study
研究组 & 干预措施
All Participants
Experimental
Lubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks
干预措施: Lubiprostone 24 (Drug)
结局指标
主要结局
Mean Weekly Bowel Movements (BMs) Per Month
时间窗: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
时间窗: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
次要结局
- Straining Associated With Spontaneous Bowel Movements by Month(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Abdominal Discomfort by Month(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Treatment Effectiveness by Month(Months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Number of Participants Classified as Monthly Responders(Months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Stool Consistency of Spontaneous Bowel Movements by Month(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Constipation Severity by Month(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Abdominal Bloating by Month(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Bowel Habit Regularity by Month(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Mean Weekly Complete SBMs by Month(Months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
- Mean Weekly Complete BMs by Month(Months 1, 2, 3, 4, 5, 6, 7, 8, and 9)
研究者
研究点 (119)
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