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

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

Official Title
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A Double-blind, Randomised, Placebo-controlled Study on the Efficacy of Iberogast® (STW5) in Patients With Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: STW5 (Iberogast, BAY98-7411)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STW5<br>2/3 patients with irritable bowel syndrome will be randomized in this arm | Drug: STW5 (Iberogast, BAY98-7411)<br>* Applied orally over 28 days, 20 drops STW 5 three times daily<br>|
| Placebo Comparator: Placebo<br>1/3 patients with irritable bowel syndrome will be randomized in this arm | Drug: Placebo<br>* Applied orally over 28 days, 20 drops placebo three times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of responders with decrease in pain intensity compared with baseline for at least 14 single days within 4 weeks of treatment | The pain intensity is documented on a 10 cm visual analogue scale (VAS) scale | 28 days (+/- 3 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of responders with decrease in pain intensity compared with baseline for at least 7 single days within first 2 weeks of treatment |  | 14 days (+/- 3 days) | 
| Score on IBS-QOL (Irritable Bowel Syndrome - Quality of Life Measure) scale |  | 28 days (+/- 3 days) | 
| Stool consistency (IBS-D): Decrease in weekly average of >1 in terms of BSS (Bristol Stool Form Scale) |  | 28 days (+/- 3 days) | 
| Stool frequency (IBS-C): Increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with Baseline |  | 28 days (+/- 3 days) | 
| Numbers of participants with adverse events (AEs) |  | 28 days (+/- 3 days) | 
| Vital signs | blood pressure, heart rate, body weight | 28 days (+/- 3 days) | 
| Laboratory parameters | haematology, blood chemistry, urinalysis | 28 days (+/- 3 days) | 
| Global assessment of tolerability on a 5-point Likert scale by Investigator and patient |  | 28 days (+/- 3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iberogast, efficacy, safety