NCT00595946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
- 439
- 试验地点
- 93
- 主要终点
- Mean Weekly Spontaneous Bowel Movements at 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.
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 (OBD) 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 inhibitor (SSRIs), Serotonin-norepinephrine reuptake inhibitor (SNRIs), or Monoamine oxidase inhibitor (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
- •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).
- •Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
- •Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
- •Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
- •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.
- •Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.
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
Mean Weekly Spontaneous Bowel Movements at Week 8
时间窗: at Week 8
Spontaneous bowel movements (SBMs) are defined as bowel movements without the aid of drugs.
次要结局
- Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks(within 12 weeks)
- Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose(within 48 hours post-dose)
- Number of Participants Classified as Responders(within 12 weeks)
- Participant Reported Outcome of Treatment Effectiveness(within 12 weeks)
- Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity(within 12 weeks)
研究者
研究点 (93)
Loading locations...
相似试验
已完成
3 期
Opioid-induced Bowel Dysfunction Pivotal Assessment of LubiprostoneOpioid-Induced Bowel DysfunctionNCT00597428Sucampo Pharma Americas, LLC437
已完成
3 期
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)Opioid-induced Bowel DysfunctionNCT01298219Sucampo Pharma Americas, LLC439
已完成
4 期
Lubiprostone in Patients With Multiple Sclerosis Associated ConstipationMultiple SclerosisConstipationNCT01236534University of Rochester21
已完成
4 期
Safety and Efficacy of Lubiprostone in Pediatric Patients With ConstipationConstipationNCT00452335Sucampo Pharma Americas, LLC127
已完成
3 期
Opioid-induced Bowel Dysfunction: Long-Term Assessment of LubiprostoneOpioid-Induced Bowel DysfunctionNCT00620061Sucampo Pharma Americas, LLC439