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

Bayer

Status and phase

Terminated

Phase 2

Conditions

Colitis, Ulcerative

Treatments

Drug: Placebo

Drug: STW5-II (Iberogast N, BAY98-7410)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02246686

2013-000891-13 (EudraCT Number)

17155

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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