Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients
NCT ID: NCT02246686
Last Updated: 2016-10-18
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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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2014-11-30
2016-04-30
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
DOUBLE
Study Groups
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STW5-II
Half of study population, assigned randomly
STW5-II (Iberogast N, BAY98-7410)
Application over 12 weeks 20 drops three time daily
Placebo
Half of study population, assigned randomly
Placebo
Application over 12 weeks 20 drops three time daily
Interventions
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STW5-II (Iberogast N, BAY98-7410)
Application over 12 weeks 20 drops three time daily
Placebo
Application over 12 weeks 20 drops three time daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 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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Dachau, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Lüneburg, Lower Saxony, Germany
Cologne, North Rhine-Westphalia, Germany
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Lübeck, Schleswig-Holstein, Germany
Berlin, , Germany
Essen, , Germany
Countries
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Other Identifiers
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2013-000891-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17155
Identifier Type: -
Identifier Source: org_study_id
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