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

Conditions: Patients with dyspeptic symptoms and delayed gastric emptying.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2011-002782-38-DE

Lead Sponsor: INFAI GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

* 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

Exclusion Criteria

* 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.