NCT00380250已完成3 期
Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation
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
- 590
- 主要终点
- Overall Responder Rate
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.
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
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
- •18 years of age and older
- •Stable fiber therapy
- •Normal colonoscopy/sigmoidoscopy
- •Able to refrain from use of medications known to treat or associated with constipation symptoms
- •Experiences abdominal discomfort/pain associated with bowel movements
- •Reports decreased bowel movement frequency and/or other symptoms associated with constipation
排除标准
- •Diarrhea-predominant or alternating (diarrhea and constipation cycling) irritable bowel syndrome (IBS), or constipation other than that associated with IBS
- •Open gastrointestinal or abdominal surgery prior to IBS onset
- •Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding
- •Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion
- •If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
研究组 & 干预措施
Lubiprostone
Experimental
8 mcg capsule twice daily (BID)
干预措施: Lubiprostone (Drug)
Placebo
Placebo Comparator
Matching placebo capsule twice daily (BID)
干预措施: Placebo (Drug)
结局指标
主要结局
Overall Responder Rate
时间窗: 12 weeks
Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase during the month; AND did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month. Overall responder: responder for at least 2/3 months
次要结局
- Month 1 Spontaneous Bowel Movement (SBM) Frequency Rates Change From Baseline(Change from baseline for month 1)
- Quality of Life Change From Baseline(Change from baseline at 12 weeks)
- Month 3 Bowel Straining Change From Baseline(Change from baseline for month 3)
- Month 1 Constipation Severity Change From Baseline(Change from baseline at 28 days)
- Month 1 Symptom Relief(Change from baseline for month 1)
- Month 2 Stool Consistency Change From Baseline(Change from baseline for month 2)
- Month 3 Responder Rate(month 3 (28 days))
- Month 3 Abdominal Bloating Change From Baseline(Change from baseline for month 3)
- Month 2 Spontaneous Bowel Movement Frequency Rates Change From Baseline(Change from baseline for month 2)
- Month 3 Spontaneous Bowel Movement Frequency Rates Change From Baseline(Change from baseline for month 3)
- Month 1 Bowel Straining Change From Baseline(Change from baseline for month 1)
- Month 2 Responder Rate(month 2 (28 days))
- Month 2 Abdominal Bloating Change From Baseline(Change from baseline for month 2)
- Month 3 Constipation Severity Change From Baseline(Change from baseline for month 3)
- Month 1 Stool Consistency Change From Baseline(Change from baseline for month 1)
- Month 1 Responder Rate(month 1 (28 days))
- Month 3 Stool Consistency Change From Baseline(Change from baseline for month 3)
- Month 2 Bowel Straining Change From Baseline(Change from baseline for month 2)
- Month 3 Symptom Relief(Change from baseline for month 3)
- Month 1 Bowel Movement Frequency Rates Change From Baseline(Change from baseline for month 1)
- Month 1 Abdominal Pain Change From Baseline(Change from baseline for month 1)
- Month 2 Abdominal Pain Change From Baseline(Change from baseline for month 2)
- Month 2 Constipation Severity Change From Baseline(Change from baseline for month 2)
- Month 2 Symptom Relief(Change from baseline for month 2)
- Month 1 Abdominal Bloating Change From Baseline(Change from baseline for month 1)
- Month 2 Bowel Movement Frequency Rates Change From Baseline(Change from baseline for month 2)
- Month 3 Bowel Movement Frequency Rates Change From Baseline(Change from baseline for month 3)
- Month 3 Abdominal Pain Change From Baseline(Change from baseline for month 3)
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