NCT02544152终止2 期
A Randomized, Double-blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Lubiprostone in Adult Subjects With Mixed or Unsubtyped Irritable Bowel Syndrome (IBS-M/IBS-U)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 71
- 试验地点
- 15
- 主要终点
- Number of Participants Classified as an Overall Responder for Abdominal Pain
研究概览
简要总结
A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.
详细描述
To assess the efficacy and safety of oral lubiprostone, as compared to matching placebo, when administered orally (at 8 mcg twice daily [BID]) in subjects diagnosed with IBS-M/IBS-U.
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
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
- •Subject meets the diagnosis of IBS-M or IBS-U as confirmed using the adapted ROME III Diagnostic Questionnaire for Adult Functional GI Disorders.
- •Subject Screening diary entries must show an average worst abdominal pain in the past 24 hours score of at least 4 on a 11-point scale.
- •Subject must be on a stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors if taking antidepressants.
排除标准
- •Subject has current diagnosis of IBS with diarrhea (IBS-D) or IBS with constipation (IBS-C), according to Rome III Criteria.
- •Any gastrointestinal (GI) condition, other than IBS-related, affecting GI motility or defecation.
- •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
Experimental
Participants receive 8 mcg lubiprostone capsules twice daily (BID)
干预措施: Lubiprostone (Drug)
Placebo
Placebo Comparator
Participants receive 0 mcg capsules BID
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Classified as an Overall Responder for Abdominal Pain
时间窗: within 12 weeks
An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks.
次要结局
- Number of Participants Classified as a Monthly Responder for Abdominal Pain(within 3 months)
- Number of Participants Classified as a Monthly Responder for Stool Consistency(within 3 months)
- Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms(within 12 weeks)
- Number of Participants Classified as a Monthly Responder for IBS Symptoms(within 3 months)
- Number of Participants Classified as a Weekly Responder for Abdominal Pain(within 12 weeks)
- Number of Participants Classified as an Overall Responder for IBS Symptoms(within 3 months)
- Number of Participants Classified as an Overall Responder for Stool Consistency(within 3 months)
- Number of Participants Classified as a Weekly Responder for Stool Consistency(within 12 weeks)
研究者
研究点 (15)
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