Efficacy/Safety Study to Confirm Iberogast's Efficacy in Patients With Irritable Bowel Syndrome Diagnosed on ROME III Criteria Compared to Placebo
NCT ID: NCT01940848
Last Updated: 2018-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
243 participants
INTERVENTIONAL
2013-10-11
2017-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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STW5
2/3 patients with irritable bowel syndrome will be randomized in this arm
STW5 (Iberogast, BAY98-7411)
Applied orally over 28 days, 20 drops STW 5 three times daily
Placebo
1/3 patients with irritable bowel syndrome will be randomized in this arm
Placebo
Applied orally over 28 days, 20 drops placebo three times daily
Interventions
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STW5 (Iberogast, BAY98-7411)
Applied orally over 28 days, 20 drops STW 5 three times daily
Placebo
Applied orally over 28 days, 20 drops placebo three times daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Ludwigsburg, Baden-Wurttemberg, Germany
Mannheim, Baden-Wurttemberg, Germany
Sinzheim, Baden-Wurttemberg, Germany
Potsdam, Brandenburg, Germany
Lollar, Hesse, Germany
Wiesbaden, Hesse, Germany
Wardenburg, Lower Saxony, Germany
Winsen, Lower Saxony, Germany
Essen, North Rhine-Westphalia, Germany
Hagen, North Rhine-Westphalia, Germany
Löhne, North Rhine-Westphalia, Germany
Marl, North Rhine-Westphalia, Germany
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Halle, Saxony-Anhalt, Germany
Reinfeld, Schleswig-Holstein, Germany
Apolda, Thuringia, Germany
Blankenhain, Thuringia, Germany
Berlin, , Germany
Berlin, , Germany
Countries
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Related Links
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Click here to find results for studies related to Bayer products.
Other Identifiers
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STW5/212-D-011-III-V
Identifier Type: OTHER
Identifier Source: secondary_id
2011-002613-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17063
Identifier Type: -
Identifier Source: org_study_id
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