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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003362-41 | EudraCT Number |
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The purpose of this study is to investigate the efficacy and safety of budesonide suppository for the treatment of acute ulcerative proctitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide dosage 1 | Experimental | Budesonide 2 mg suppository |
|
| Budesonide dosage 2 | Experimental | Budesonide 4 mg suppository |
|
| Mesalazine | Active Comparator | Mesalazine 1g suppository |
|
| Combination | Experimental | Budesonide 2 mg suppository/Mesalazine 1 g suppository |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide 2 mg suppository | Drug | per day |
| |
| Budesonide 4 mg suppository |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of clinical symptoms | Symptoms as reported in the diary | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinical and endoscopic remission | Symptoms as reported in the diary, ulcerative colitis-disease activity index | 8 weeks |
| Rate of improvement | Symptoms as reported in the diary, ulcerative colitis-disease activity index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Kruis, Professor | Evang. Krankenhaus Kalk, Medical Department | Principal Investigator |
| Britta Siegmund, Professor | Charité-Campus Benjamin Franklin Universitätsmedizin Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité-Campus Benjamin Franklin Universitätsmedizin Berlin | Berlin | 12203 | Germany | |||
| Evang. Krankenhaus Kalk, Medical Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29702300 | Result | Kruis W, Neshta V, Pesegova M, Alekseeva O, Andreev P, Datsenko O, Levchenko O, Abdulkhakov S, Lozynskyy Y, Mostovoy Y, Soloviev K, Dorofeyev AE, Vieth M, Stiess M, Greinwald R, Mohrbacher R, Siegmund B. Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis. Clin Gastroenterol Hepatol. 2019 Jan;17(1):98-106.e4. doi: 10.1016/j.cgh.2018.04.027. Epub 2018 Apr 24. |
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| Drug |
per day |
|
| Mesalazine 1 g suppository | Drug | per day |
|
| Budesonide 2 mg suppository/Mesalazine 1 g suppository | Drug | per day |
|
| 8 weeks |
| Rate of patients with clinical remission | Symptoms as reported in the diary, ulcerative colitis-disease activity index | 8 weeks |
| Rate of patients with endoscopic remission | Ulcerative colitis-disease activity index | 8 weeks |
| Cologne |
| 51103 |
| Germany |
| ID | Term |
|---|---|
| D011349 | Proctitis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D013488 | Suppositories |
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
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