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

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
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Iberogast (STW5, BAY98-7411)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Wardenburg, Germany, 26203

Status
Completed
 
Locations

Investigative Site

Marl, Germany, 45770

Status
Completed
 
Locations

Investigative Site

Hagen, Germany, 58095

Status
Completed
 
Locations

Investigative Site

Lollar, Germany, 35457

Status
Completed
 
Locations

Investigative Site

Winsen, Germany, 21423

Status
Completed
 
Locations

Investigative Site

Ludwigshafen, Germany, 67067

Status
Completed
 
Locations

Investigative Site

Wiesbaden, Germany, 65185

Status
Completed
 
Locations

Investigative Site

Potsdam, Germany, 14482

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 12157

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 13055

Status
Completed
 
Locations

Investigative Site

Mannheim, Germany, 68165

Status
Completed
 
Locations

Investigative Site

Essen, Germany, 45355

Status
Completed
 
Locations

Investigative Site

Halle, Germany, 06108

Status
Completed
 
Locations

Investigative Site

Blankenhain, Germany, 99444

Status
Completed
 
Locations

Investigative Site

Apolda, Germany, 99510

Status
Completed
 
Locations

Investigative Site

Löhne, Germany, 32584

Status
Completed
 
Locations

Investigative Site

Sinzheim, Germany, 76547

Status
Completed
 
Locations

Investigative Site

Ludwigsburg, Germany, 71640

Status
Completed
 
Locations

Investigative Site

Reinfeld, Germany, 23858

Status
Completed
 

Trial Design