EUCTR2008-001886-26-GR进行中（未招募）不适用
A multicenter, double-blind, randomized, placebo controlled phase III study of the efficacy and safety of Trimebutine 300 mg twice daily for the relief of functional dyspeptic patients
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A subject is eligible for inclusion in this study only if all of the following criteria apply:
- •1.Ambulant male and non pregnant female subjects.
- •2.Age between 18 and 75 years old (including the limits) at the randomisation visit.
- •3.History of epigastric pain or discomfort at least 1 of the last 7 days before randomisation.
- •4.Normal macroscopic findings from oesophagus, stomach and duodenum during the endoscopy which will take place 10 days (±4 days) prior to enrolment.
- •5.Willing and able to sign the informed consent prior to entry into the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects will not be eligible for inclusion in this study if any of the following conditions apply:
- •1.Alarm symptoms (loss of weight, vomit, hematemesis, melaena, fever, icterus or any other sign which indicates serious or virulent disease).
- •2.Irritable Bowel Syndrome (IBS) as it was defined by Rome Criteria II (1999); abdominal pain for at least 12 weeks (not necessarily sequential) which has 2 or more of the below characteristics:
- •?Relieved with evacuation.
- •?Change at the frequency of the evacuations.
- •?Constitution of excrements.
- •3.Chronic serious constipation.
- •4.Patients with retrosternal burning pain.
- •5.History of serious or uncontrolled diseases.
- •6.History of peptic ulcer (endoscopy or radiogram) or gastroesophagical reflux disease (endoscopy), gastritis or other significant gastrointestinal disease.
- •7.History of peptic or other abdominal surgery (appendectomy and gynaecological surgeries excluded).
- •8.Patients with history of gallbladder surgery.
- •9.Pregnancy (examined with blood test) or breastfeeding.
- •10. Participation in a clinical trial within the previous month or current participation in any other clinical research study or clinical trial.
- •11.Abnormal physical, haematology and biochemistry examinations prior to enrolment (according to the investigator’s decision).
- •12.Use of non steroid antiflammatory drugs (during the study).
- •13.Usage of drugs that from the investigators point of view could cause dyspeptic symptoms.
- •14.Alcoholism or psychic disease which could lead to non compliance with the investigator’s instructions.
- •15. Known Hypersensitivity to drastic substance.
研究者
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