A double-blind, randomised, placebo controlled crossover study on the effects of 100mg, three times daily, Z-338 on the symptomatic response to a nutrient challenge and gasteric nutrient distribution and emptying in subjects with and without functional dyspepsia.

Zeria Pharmaceutical Co., Ltd0 个研究点目标入组 52 人开始时间: 2005年12月16日最近更新: 2020年1月13日

适应症

试验速览

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•(Subjects with no history of functional dyspepsia):1) Clinical assessment, physical examination and laboratory testing without evidence for relevant abnormality (e.g. no need for further clinical testing)Inclusion criteria (Subjects with functional dyspepsia):1) Diagnosis of functional dyspepsia according to Rome II criteria and three or more moderate symptoms of Gastrointestinal Symptom Score.

•(All subjects):1) previous abdominal or gynaecological surgery (except appendectomies, vaginal hysterectomy, diagnostic laparscope and other as determined by Investigator).2) previous gastrointestinal cancer, previous malignancy, except non-metastatic basak or squamous cell carcinoma cancer within the last five years.3) known current peptic ulcer disease4) predominant gastro-esophageal reflux symptoms or Irritable Bowel Syndrome.5) pregnancy or breast feeding6) Treatment with antibiotics 8 weeks prior7) Taking acid suppressing medications (proton pump inhibitors, histamine 2 receptor antagonist, antacids), prokinetics (e.g. Cisapride, Maroon) for 2 weeks.8) Diabetes on continuous medical therapy9) clinically relevant cardiovascular disease (as assessed by the Investigator)10) Any clinically relevant uncontrolled medical condition (as assessed by the investigator)11) No other clinical trials within the last 30 days12) Subject has not been a volunteer in any other research projects which have involved radioactivity exposure in the last twelve months.13) Subject testing positive for Helicobacter pylori.

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