Trial Condition(s):

Irritable bowel syndrome

Efficacy/Safety study to confirm Iberogast's efficacy in patients with irritable bowel syndrome diagnosed on ROME III criteria compared to placebo

Bayer Identifier:

17063

ClinicalTrials.gov Identifier:

NCT01940848

EudraCT Number:

2011-002613-10

EU CT Number:

Not Available

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
243
Trial Dates
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Phase
3
Could I receive a placebo?
Yes
Products
Iberogast (STW5, BAY98-7411)
Accepts Healthy Volunteers
No

Where to Participate

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Investigative Site

Wardenburg, Germany, 26203

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Marl, Germany, 45770

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Hagen, Germany, 58095

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Lollar, Germany, 35457

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Winsen, Germany, 21423

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Ludwigshafen, Germany, 67067

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Wiesbaden, Germany, 65185

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Potsdam, Germany, 14482

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Berlin, Germany, 12157

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Berlin, Germany, 13055

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Mannheim, Germany, 68165

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Essen, Germany, 45355

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Halle, Germany, 06108

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Blankenhain, Germany, 99444

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Apolda, Germany, 99510

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Löhne, Germany, 32584

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Sinzheim, Germany, 76547

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Ludwigsburg, Germany, 71640

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Investigative Site

Reinfeld, Germany, 23858

Trial Design