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

Phase 2TerminatedNCT02246686

Bayer3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Colitis, Ulcerative

Interventions

STW5-II (Iberogast N, BAY98-7410)DRUG

Application over 12 weeks 20 drops three time daily

PlaceboDRUG

Application over 12 weeks 20 drops three time daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Dachau, Bavaria, Germany

Unnamed facility

Hamburg, Hamburg, Germany

Unnamed facility

Lüneburg, Lower Saxony, Germany

Unnamed facility

Cologne, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Proportion of patients being in remission at final visit

Responder definition for remission: Clinical Activity Index (CAI) ≤ 4

Time frame: Week 12

Change of endoscopic index (EI)

Time frame: From baseline to week 12

Change of histological index (HI) based on Riley

Time frame: From baseline to week 12

Proportion of patients reaching a clinical CAI ≤ 2 points

Time frame: 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

Time frame: Up to 12 weeks

Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached

Time frame: Up to 12 weeks

Number of patients who reached a remission at least once during the course of the study

Time frame: Week 12

Number of patients who reached a sustained remission at least once during the course of the study

Time frame: Week 12

Change from baseline of absolute CAI values to final visit

Time frame: From baseline to week 12

Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit

Time frame: From baseline to week 12

Data from ClinicalTrials.gov

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