Gastromotal 13C-octanoic acid breath test in the diagnosis and evaluation of therapeutic outcome in patients with dyspeptic symptoms and delayed gastric emptying - 13COBT

INFAI GmbH0 个研究点目标入组 60 人开始时间: 2012年4月10日最近更新: 2014年1月27日

适应症

试验速览

暂无简介。

•* Male or female patients of at least 18 years of age
•* Patients suffering from dyspeptic symptoms (GSRS summary score =6, at least 3 symptoms including the symptom fullness or epigastric pain with a score GSRS =2 each)
•* Exclusion of organic causes for functional dyspepsia by breath test for the presence of H. pylori and gastroscopy within 12 weeks prior to enrolment.
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•* Patients with contraindications for the treatment with domperidon (Motilium®): hypersensitivity to domperidon, prolactinome, liver insufficiency, therapy with Ketoconazol-derivates
•* Patients with medication known to influence gastric emptying
•* Patient with concomitant medication known to worsen dyspeptic symptoms (i.e. NSAIDs).
•* Patients with Type I or II Diabetes Mellitus
•* Patients with pathological finding in gastroscopy within 12 weeks prior to enrolment
•* Patients with positive breath test for H. pylori within 12 weeks prior to enrolment
•* Patients with chronic liver insufficiency
•* Pregnant or breastfeeding female patients.

发起方

INFAI GmbH