跳至主要内容
临床试验/NCT01678781
NCT01678781已完成不适用

Open International Study on Quality of Life in IBS Patients Before and After 8 Weeks Treatment With Mebeverine/Pinaverium Bromide

Abbott24 个研究点 分布在 4 个国家目标入组 607 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Abbott
入组人数
607
试验地点
24
主要终点
Change in Irritable Bowel syndrome (IBS) quality of life (QoL) measure (IBS-QoL) to assess the impairment of QoL in IBS patients

研究概览

简要总结

A study to evaluate, by country and overall, the changes from baseline of the irritable bowel syndrome quality of life (IBS QoL) total score after 4 and 8 weeks of treatment with Duspatalin® or Dicetel® in IBS patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Irritable bowel syndrome patients diagnosed by Rome III criteria (18 years or older)

排除标准

  • Pregnancy and lactation
  • Specific contraindications to mebeverine hydrochloride or pinaverium bromide

结局指标

主要结局

Change in Irritable Bowel syndrome (IBS) quality of life (QoL) measure (IBS-QoL) to assess the impairment of QoL in IBS patients

时间窗: From baseline up to the week 8 visit

次要结局

  • Change in abdominal pain(From baseline up to the week 8 visit)
  • Change in bloating(From baseline up to the week 8 visit)
  • Change in feeling of abdominal distension(From baseline up to the week 8 visit)
  • Change in stool frequency(From baseline up to the week 8 visit)
  • Change in stool form(From baseline up to the week 8 visit)
  • Change in straining of evacuation(From baseline up to the week 8 visit)
  • Change in urgency of evacuation(From baseline up to the week 8 visit)
  • Change in feeling of incomplete evacuation(From baseline up to the week 8 visit)

研究者

发起方
Abbott
申办方类型
Industry
责任方
Sponsor

研究点 (24)

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