NCT00597428已完成3 期
A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)
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
- 437
- 试验地点
- 113
- 主要终点
- Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening.
- •Diagnosis of opioid-induced bowel dysfunction as confirmed during the screening period.
- •If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment.
- •Use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.
- •If treated for clinical depression with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening.
- •Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study.
排除标准
- •Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
- •Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
- •Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.
- •Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
- •Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
- •Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.
研究组 & 干预措施
Placebo
Placebo Comparator
0 mcg capsules twice daily (BID)
干预措施: Placebo (Drug)
Lubiprostone
Experimental
24 mcg capsules twice daily (BID)
干预措施: Lubiprostone (Drug)
结局指标
主要结局
Change From Baseline in Mean Weekly Spontaneous Bowel Movement (SBM) Frequency in Subjects Without Dose Reduction Prior to Week 8
时间窗: Baseline and Week 8
次要结局
- Change From Baseline in Mean Weekly SBM Frequency(Baseline, Week 12, and Weeks 1-12)
- First Post-dose SBM(24 and 48 hours post-dose)
- Responder Rate(Up to 12 weeks)
- Mean Changes From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity(Weeks 1-12)
- Treatment Effectiveness(Weeks 1-12)
研究者
研究点 (113)
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