Efficacy/Safety Study to Confirm Iberogast's Efficacy in Patients With Irritable Bowel Syndrome Diagnosed on ROME III Criteria Compared to Placebo

• Status: Completed
• Trial end date: 2017-10-25
• Target enrollment: 0
• Participant gender: All

Summary

The study shall prove whether treatment of irritable bowel syndrome with Iberogast is superior to placebo regarding the main criterium "pain"

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

Inclusion Criteria:

• Patients of either sex aged >18 years

• Patients meeting the Rome III irritable bowel syndrome (IBS) diagnostic criteria. IBS is defined as recurrent abdominal pain or discomfort at least 3 days/month in last 3 months (onset at least 6 months ago) associated with two or more of the following:

• Improvement with defecation

• Onset associated with a change in frequency of stool

• Onset associated with a change in form (appearance) of stool

• History of pain intensity with an average of worst abdominal pain in past 24 hours score of > 30 on a daily measured VAS (visual analogue scale) during screening phase

Exclusion Criteria:

• Intake of STW5 within the last 5 years

• Concomitant treatment during the study (including screening phase) with any medication that could influence the gastrointestinal function

• Regular intake of nonsteroidal antiphlogistic drugs incl. COX-2-inhibitors (exception:

acetylsalicylic acid for cardiovascular prevention up to 100 mg daily)

• Patients with known hypersensitivity to any component of the trial drugs

• History of eating disorders

• Patients with a history of diseases with abdominal symptoms that can resemble IBS

• Presence of any other acute or chronic gastrointestinal disorder

• History of abdominal surgery (cholecystectomy and appendectomy can be tolerated when performed at least one year previously)

• Known intolerance to azo dyes E 110 and E 151