Phase 3, 12-Week, Multicenter, Double-Blind, Randomized, Efficacy and Safety Study of Lubiprostone for the Treatment of Irritable Bowel Syndrome With Constipation

Sucampo Pharma Americas, LLC0 个研究点目标入组 581 人开始时间: 2005年5月最近更新: 2019年12月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Sucampo Pharma Americas, LLC
入组人数: 581
主要终点: Overall Responder Status

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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 & constipation cycling) 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

结局指标

主要结局

Overall Responder Status

时间窗: 12 weeks

Overall responder: monthly responder for at least 2 out of 3 months Monthly responder: \>=Moderately relieved symptoms 4 weeks/month or Significantly relieved \>= 2 weeks/month IF: Rescue med use did not increase; AND patient did not discontinue during the month for lack of efficacy; AND no Moderately worse or Significantly worse response in month.

次要结局

Month 3 Abdominal Bloating Change From Baseline(28 days)
Month 2 Responder Rate(28 days)
Month 3 Responder Rate(28 days)
Month 3 Constipation Severity Change From Baseline(28 days)
Month 1 Stool Consistency Change From Baseline(28 days)
Month 2 Symptom Relief(28 days)
Month 1 Constipation Severity Change From Baseline(28 days)
Month 1 Symptom Relief(28 days)
Month 2 Abdominal Bloating Change From Baseline(28 days)
Month 2 Spontaneous Bowel Movement Rates Change From Baseline(28 days)
Month 2 Stool Consistency Change From Baseline(28 days)
Month 1 Bowel Movement Rates Change From Baseline(28 days)
Month 1 Spontaneous Bowel Movement Rates Change From Baseline(28 days)
Month 1 Bowel Straining Change From Baseline(28 days)
Month 1 Abdominal Pain Change From Baseline(28 days)
Month 2 Abdominal Pain Change From Baseline(28 days)
Month 1 Abdominal Bloating Change From Baseline(28 days)
Month 3 Stool Consistency Change From Baseline(28 days)
Month 1 Responder Rate(28 days)
Month 3 Abdominal Pain Change From Baseline(28 days)
Month 3 Spontaneous Bowel Movement Rates Change From Baseline(28 days)
Month 2 Bowel Straining Change From Baseline(28 days)
Month 3 Bowel Straining Change From Baseline(28 days)
Month 2 Constipation Severity Change From Baseline(28 days)
Month 3 Symptom Relief(28 days)
Month 3 Quality of Life Change From Baseline(12 weeks)
Month 2 Bowel Movement Rates Change From Baseline(28 days)
Month 3 Bowel Movement Rates Change From Baseline(28 days)

研究者

发起方

Sucampo Pharma Americas, LLC

申办方类型

Industry

责任方

Sponsor

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