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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Essen, Germany, 45276 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Berlin, Germany, 14109 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ludwigshafen, Germany, 67067 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dachau, Germany, 85221 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Köln, Germany, 50937 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lübeck, Germany, 23538 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lüneburg, Germany, 21339 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 20249 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomised, double-blind, placebo-controlled multi-centre study to investigate the effectiveness and safety of STW5-II as add-on treatment for induction of remission in patients with mild to moderate ulcerative colitis
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Proportion of patients being in remission at final visitResponder definition for remission: Clinical Activity Index (CAI) ≤ 4Timeframe: Week 12
- Change of endoscopic index (EI)Timeframe: From baseline to week 12
- Change of histological index (HI) based on RileyTimeframe: From baseline to week 12
- Proportion of patients reaching a clinical CAI ≤ 2 pointsTimeframe: Week 12
- Time to remission, defined as days from Day 0 until first remission is reachedResponder definition for remission: Clinical Activity Index (CAI) ≤ 4Timeframe: Up to 12 weeks
- Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reachedTimeframe: Up to 12 weeks
- Number of patients who reached a remission at least once during the course of the studyTimeframe: Week 12
- Number of patients who reached a sustained remission at least once during the course of the studyTimeframe: Week 12
- Change from baseline of absolute CAI values to final visitTimeframe: From baseline to week 12
- Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visitTimeframe: From baseline to week 12
- Change from baseline in Irritable Bowel Severity Score (IBSS) at final visitTimeframe: From baseline to week 12
- Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visitTimeframe: From baseline to week 12
- Mayo Score throughout the studyTimeframe: Up to 12 weeks
- Change of of oral mesalazine dose throughout the study periodTimeframe: From baseline to week 12
- Change in ulcerative colitis (UC) markersCombination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patientsTimeframe: From baseline to week 12
Additional Information
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