NCT00067561已完成3 期
A Twelve-Week, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of 0.5 mg QD, 1 mg QD and 1 mg BID of Alosetron in Female Subjects With Severe Diarrhea-predominant IBS Who Have Failed Conventional Therapy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 702
- 试验地点
- 179
- 主要终点
- Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
- •Failed conventional therapy.
- •Willing to make daily calls on a touch-tone telephone.
- •Exclusion criteria:
- •History of or current chronic or severe constipation.
- •Bloody diarrhea, abdominal pain with rectal bleeding.
- •Thrombophlebitis.
- •Abnormal thyroid stimulating hormone (TSH) value.
- •Alcohol and/or substance abuse within past two years.
- •Pregnant or lactating.
- •History/treatment of malignancy within past five years.
排除标准
- 未提供
结局指标
主要结局
Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.
次要结局
- Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.
研究者
研究点 (179)
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