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The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinical remission at final/withdrawal visit | Clinical remission includes normalisation of stool frequency and absence of blood in stools | 8 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of endoscopic remission/improvement at final/withdrawal visit | 8 weeks treatment | |
| Number of stools / bloody stools per week | 8 weeks treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Fellermann, MD | University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Schleswig-Holstein | Lübeck | Schleswig-Holstein | 23538 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33028169 | Derived | Fellermann K, Schiefke I, Racz I, Derova J, Jonaitis L, Wehrum S, Nacak T, Greinwald R. Efficacy and safety of prolonged release budesonide granules in mesalazine-refractory ulcerative colitis: A multi-centre Phase IIa study (TOPICAL-1). United European Gastroenterol J. 2020 Dec;8(10):1186-1195. doi: 10.1177/2050640620962632. Epub 2020 Oct 7. |
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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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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |