Trial Condition(s):

Colitis, Ulcerative

Efficacy/Safety pilot study to investigate Iberogast N's efficacy in mild to moderate colitis ulcerosa patients

Bayer Identifier:

17155

ClinicalTrials.gov Identifier:

NCT02246686

EudraCT Number:

2013-000891-13

Terminated/Withdrawn

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
3
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Iberogast N (STW5-II, BAY98-7410)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Essen, Germany, 45276

Status
Terminated
 
Locations

Investigative Site

Berlin, Germany, 14109

Status
Terminated
 
Locations

Investigative Site

Ludwigshafen, Germany, 67067

Status
Terminated
 
Locations

Investigative Site

Dachau, Germany, 85221

Status
Completed
 
Locations

Investigative Site

Köln, Germany, 50937

Status
Terminated
 
Locations

Investigative Site

Lübeck, Germany, 23538

Status
Terminated
 
Locations

Investigative Site

Lüneburg, Germany, 21339

Status
Terminated
 
Locations

Investigative Site

Hamburg, Germany, 20249

Status
Terminated
 

Trial Design