Status:
TERMINATED
Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients
Lead Sponsor:
Bayer
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02246686
Start Date
November 1 2014
End Date
April 1 2016
Last Update
October 18 2016
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Dachau, Bavaria, Germany, 85221
2
Hamburg, Hamburg, Germany, 20249
3
Lüneburg, Lower Saxony, Germany, 21339
4
Cologne, North Rhine-Westphalia, Germany, 50937