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

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

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