NCT00067457已完成3 期
A 12-Week, Randomized, Double-Blind, Placebo- Controlled Study of PRN BID and Fixed Dosing Regimens of Alosetron in Female Subjects With Severe Diarrhea-Predominant Irritable Bowel Syndrome 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
- 700
- 试验地点
- 192
- 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 as needed versus fixed dosing of an investigational medication for 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.
排除标准
- •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.
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.
时间窗: 12 Weeks
次要结局
- Comparison of treatment groups with respect to subject relief of IBS pain & discomfort; lower GI symptoms, changes in quality of life, lost workplace productivity, & lost household/leisure activity, & subject satisfaction with assigned study drug.(12 Weeks)
研究者
研究点 (192)
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