Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients

Study Overview
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Brief Summary
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The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in patients with mild to moderate ulcerative colitis in an acute flare.

Official Title
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A Randomised, Double-blind, Placebo-controlled Multi-centre Study to Investigate the Effectiveness and Safety of STW5-II as add-on Treatment for Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Drug: STW5-II (Iberogast N, BAY98-7410)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with mild to moderate active ulcerative colitis (UC), i.e. Clinical Activity Index (CAI) ≥ 5 up to 10 points (including) Patients in whom the active UC is treated independent from any participation in the current study with oral mesalazine at least 14 days up to maximal 28 days before Visit 2 Age between 18 to 80 years (including) UC may reach from left-sided colitis to pancolitis Exclusion Criteria: Severe forms of UC (CAI > 10) Crohn's disease, infectious colitis or undetermined colitis Steroid dependence and steroid resistance Concomitant medication with oral steroids, oral or topic budesonide, biologicals, immune modifiers, immunosuppressants Antibiotics at screening visit, during the course of the study a short-term use in non-colitic afflictions is allowed, and is documented Prior medication with biologicals, immune modifiers and immunosuppressants < 3 month wash-out Total colectomy Known allergies to components of STW5-II Severe allergic diathesis Topical mesalazine application Known intolerance to azo dyes E110 and E151

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STW5-II<br>Half of study population, assigned randomly | Drug: STW5-II (Iberogast N, BAY98-7410)<br>* Application over 12 weeks 20 drops three time daily<br>|
| Placebo Comparator: Placebo<br>Half of study population, assigned randomly | Drug: Placebo<br>* Application over 12 weeks 20 drops three time daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients being in remission at final visit | Responder definition for remission: Clinical Activity Index (CAI) ≤ 4 | Week 12 | 
| Change of endoscopic index (EI) |  | From baseline to week 12 | 
| Change of histological index (HI) based on Riley |  | From baseline to week 12 | 
| Proportion of patients reaching a clinical CAI ≤ 2 points |  | Week 12 | 
| Time to remission, defined as days from Day 0 until first remission is reached | Responder definition for remission: Clinical Activity Index (CAI) ≤ 4 | Up to 12 weeks | 
| Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached |  | Up to 12 weeks | 
| Number of patients who reached a remission at least once during the course of the study |  | Week 12 | 
| Number of patients who reached a sustained remission at least once during the course of the study |  | Week 12 | 
| Change from baseline of absolute CAI values to final visit |  | From baseline to week 12 | 
| Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit |  | From baseline to week 12 | 
| Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit |  | From baseline to week 12 | 
| Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit |  | From baseline to week 12 | 
| Mayo Score throughout the study |  | Up to 12 weeks | 
| Change of of oral mesalazine dose throughout the study period |  | From baseline to week 12 | 
| Change in ulcerative colitis (UC) markers | Combination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients | From baseline to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iberogast N, Mild to moderate ulcerative colitis, add-on therapy, efficacy