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临床试验/NCT00298194
NCT00298194已完成2 期

The Effects of Z-338 on the Symptomatic Response to a Nutrient Challenge and Gastric Nutrient Distribution and Emptying in Subjects With and Without Functional Dyspepsia

Zeria Pharmaceutical2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2006年2月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
52
试验地点
2

研究概览

简要总结

To assess in subjects with and without functional dyspepsia the effects of Z-338 on:

  1. Type and severity of symptoms a standardized nutrient challenge
  2. The gastric nutrient distribution and gastric emptying of a standardized nutrient challenge
  3. The association of the above with the manifestations of symptoms and symptom pattern

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • Subjects with functional dyspepsia Positive documented diagnosis of FD via RomeII criteria and three or more moderate symptoms of Gastrointestinal Score
  • Subjects with no history of functional dyspepsia Clinical assessment, physical examination and laboratory testing without evidence for relevant abnormality.
  • Other protocol-defined inclusion/

排除标准

  • 未提供

研究者

发起方
Zeria Pharmaceutical
申办方类型
Industry

研究点 (2)

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