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临床试验/NCT00189813
NCT00189813已完成2 期

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Potential Efficacy, Safety and Tolerability of Different Oral Doses of YM060 in Patients With Diarrhea-predominant Irritable Bowel Syndrome

Astellas Pharma Inc45 个研究点 分布在 8 个国家目标入组 691 人开始时间: 2005年3月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
691
试验地点
45

研究概览

简要总结

This study will examine the efficacy, safety and tolerability of different oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS

排除标准

  • Patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding IBS), blood diseases, or neurological or psychiatric diseases
  • Patient reported having any Type 1 or Type 2 stool on the Bristol Stool Form Scale during the run-in period

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (45)

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