Colitis, Ulcerative
Conditions
Keywords
Iberogast N, Mild to moderate ulcerative colitis, add-on therapy, efficacy
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.
Interventions
DRUGSTW5-II (Iberogast N, BAY98-7410)
Application over 12 weeks 20 drops three time daily
DRUGPlacebo
Application over 12 weeks 20 drops three time daily
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients being in remission at final visit | Week 12 | Responder definition for remission: Clinical Activity Index (CAI) ≤ 4 |
| Change of endoscopic index (EI) | From baseline to week 12 | — |
| Change of histological index (HI) based on Riley | From baseline to week 12 | — |
| Proportion of patients reaching a clinical CAI ≤ 2 points | Week 12 | — |
| Time to remission, defined as days from Day 0 until first remission is reached | Up to 12 weeks | Responder definition for remission: Clinical Activity Index (CAI) ≤ 4 |
| Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached | Up to 12 weeks | — |
| Number of patients who reached a remission at least once during the course of the study | Week 12 | — |
| Number of patients who reached a sustained remission at least once during the course of the study | Week 12 | — |
| Change from baseline of absolute CAI values to final visit | From baseline to week 12 | — |
| Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit | From baseline to week 12 | — |
| Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit | From baseline to week 12 | — |
| Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit | From baseline to week 12 | — |
| Mayo Score throughout the study | Up to 12 weeks | — |
| Change of of oral mesalazine dose throughout the study period | From baseline to week 12 | — |
| Change in ulcerative colitis (UC) markers | From baseline to week 12 | Combination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients |
Countries
Germany
Outcome results
None listed