Status:
COMPLETED
Study in Patients Suffering From Heartburn and Backward Flow of Stomach Liquid Into the Esophagus
Lead Sponsor:
Bayer
Conditions:
Functional Gastrointestinal Disorders
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
In this study researchers want to learn more about the effectiveness of Iberogast® in patients with irritable stomach and concomitant chronic or recurrent heartburn and backward flow of stomach liquid...
Eligibility Criteria
Inclusion
- Patients of either sex aged 18-80 years.
- Diagnosis of functional dyspepsia according to Rome III criteria:
- Pain or burning localized to the epigastrium of at least moderate severity at least once per week with a total duration of at least 6 months.
- Pain was intermittent.
- Pain was not generalized or localized to other abdominal or chest regions.
- Pain was not relieved by defecation or passage of flatus.
- Pain did not fulfil criteria for gallbladder and sphincter of Oddi disorders.
- At assessment (visit 1 or 3) three items of GIS had to be judged at least as moderate including reflux symptoms, but reflux symptoms not dominating the clinical picture.
- Endoscopy of the upper gastrointestinal tract and abdominal sonography without pathological findings that could have explained the symptoms (findings of up to 5 gastric erosions could be tolerated if patient had no concomitant intake of acetylsalicylic acid).
- Patients willing to comply with the study protocol.
- Patients who were able to understand and provide written informed consent to participate in the trial (signed informed consent).
Exclusion
- 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, antidiarrheics).
- Regular intake of nonsteroidal antiphlogistic drugs incl. cyclooxygenase-2 (COX-2)-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily).
- History of clinically relevant gastrointestinal disease such as gastric-, pancreatic-, colon-, rectal-cancer.
- History of gastric and/or duodenal ulcer.
- History of abdominal surgery (cholecystectomy and appendectomy could be tolerated).
- History and/or presence of coronary heart disease.
- Known intolerance to azo dyes E 110 and E 151.
- Food allergies and known lactose intolerance.
- Evidence of any gastrointestinal infectious diseases.
- Participation in a clinical trial 30 days prior to this trial.
- Concurrent participation in another clinical trial.
- Female patients of childbearing potential with a positive pregnancy test, breast feeding, or female patients of childbearing potential without adequate contraception.
- History and/or presence of drug or alcohol abuse.
- Patients with psychiatric illness.
- Irritable bowel syndrome.
Key Trial Info
Start Date :
June 18 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04059900
Start Date
June 18 2009
End Date
May 3 2013
Last Update
September 19 2019
Active Locations (1)
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1
Many locations
Multiple Locations, Germany