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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000891-13 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STW5-II | Experimental | Half of study population, assigned randomly |
|
| Placebo | Placebo Comparator | Half of study population, assigned randomly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STW5-II (Iberogast N, BAY98-7410) | Drug | Application over 12 weeks 20 drops three time daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients being in remission at final visit | Responder definition for remission: Clinical Activity Index (CAI) ≤ 4 | Week 12 |
| 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 | Responder definition for remission: Clinical Activity Index (CAI) ≤ 4 | Up to 12 weeks |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dachau | Bavaria | 85221 | Germany | |||
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Placebo |
| Drug |
Application over 12 weeks 20 drops three time daily |
|
| 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 | Combination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients | From baseline to week 12 |
| Hamburg |
| Free and Hanseatic City of Hamburg |
| 20249 |
| Germany |
| Lüneburg | Lower Saxony | 21339 | Germany |
| Cologne | North Rhine-Westphalia | 50937 | Germany |
| Ludwigshafen am Rhein | Rhineland-Palatinate | 67067 | Germany |
| Lübeck | Schleswig-Holstein | 23538 | Germany |
| Berlin | 14109 | Germany |
| Essen | 45276 | Germany |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |