Patients with typical symptoms of functional dyspepsia (intermittent pain or burning localized to the epigastrum of at least moderate severity at least once per week with a total duration of at least 6 months) according to ROME III criteria and three items of GIS judged at least as moderate including reflux symptoms at Visit 1 or 3.
Conditions
Interventions
Trade Name: Iberogast
Product Name: STW-5
Pharmaceutical Form: Oral drops, solution
Other descriptive name: Iberis amara
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration nu
Sponsors
Steigerwald Arzneimittelwerk GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show the superiority of STW 5 compared to placebo for the treatment of patients with functional dyspepsia with concomitant reflux symptoms;Secondary Objective: To assess the safety and tolerability of STW 5 and to assess the effect of STW 5 on the esophageal pH-profile and reflux characteristic.;Primary end point(s): AUC of patients` assessment of gastrointestinal symptoms evaluated by daily VAS scale | — |
Countries
Germany
Outcome results
None listed