EUCTR2008-002305-40-DE进行中（未招募）不适用
A double-blind, randomised, placebo-controlled study on the Efficacy of Iberogast® (STW 5) in patients with functional dyspepsia and concomitant reflux symptoms measured with impedance and wireless pH monitoring
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •1.Patients of either sex aged 18-80 years.
- •2.Diagnosis of functional dyspepsia according to Rome III criteria:
- •3.At assessment (Visit 1 or 2) three items of GIS have to be judged at least as moderate including reflux symptoms, but reflux symptoms not dominating the clinical picture
- •4.Endoscopy of the upper gastrointestinal tract and abdominal sonography without pathological findings that could explain the symptoms (findings of up to 5 gastric erosions can be tolerated if patient has no concomitant intake of acetylsalicylic acid)
- •5.Patients willing to comply with the study protocol.
- •6.Patients who are able to understand and provide written informed consent to participate in the trial (signed informed consent).
- •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
- •1.Concomitant treatment during the study with any medication that could influence the gastrointestinal function (e.g. prokinetics, antacids, antibiotics, antidepressant, laxatives, calcium antagonists, beta-blocker, antidiarrhetics)
- •2.Regular intake of nonsteroidal antiphlogistic drugs incl. COX-2-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily)
- •3.History of clinically relevant gastrointestinal disease such as gastric-, pancreatic-, colon-, rectal-cancer
- •4.History of gastric and/or duodenal ulcer
- •5.History of abdominal surgery (cholecystectomy and appendectomy can be tolerated)
- •6.Food allergies and known lactose intolerance
- •7.Evidence of any gastrointestinal infectious diseases
- •8.Participation in a clinical trial 30 days prior to this trial
- •9.Concurrent participation in another clinical trial
- •10.Female patients of childbearing potential with a positive pregnancy test, breast feeding, or female patients of childbearing potential without adequate contraception.
- •11.History and/or presence of drug or alcohol abuse
- •12.Patients with psychiatric illness
- •13.No irritable bowel
研究者
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