NCT00394186已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Crossover, Phase IIa Study to Evaluate Efficacy and Safety of the Beta-3-Adrenergic Receptor Agonist Solabegron in Subjects With Irritable Bowel Syndrome
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 20
- 主要终点
- completion of questionnaires by the subject, determining the average adequate relief rate
研究概览
简要总结
This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve IBS pain or discomfort and associated symptoms in IBS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Diagnosis of IBS which meets the Rome II criteria, screening pain score to be > 1.5 (0= no pain, 4 = very severe pain)
排除标准
- •Subjects not meeting the Rome II criteria for the diagnosis of IBS
- •Subjects with no stool for 7 days during the screen
结局指标
主要结局
completion of questionnaires by the subject, determining the average adequate relief rate
时间窗: during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2)
次要结局
- clinical lab tests(Weeks 1, 6, 12, 18, 24)
- Blood levels of GW427353(Week 1, 13)
- Questionnaire(Weeks 1, 6, 12, 18, 24)
- ECG, vital signs, adverse events(each visit)
研究者
研究点 (20)
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