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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No.: 2004-001218-15 |
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This study intends to study the efficacy and tolerability of once daily 3.0 g mesalazine granules vs. once daily 1.5 g mesalazine granules vs. three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3.0g OD | Experimental |
| |
| 1.5g OD | Experimental |
| |
| 0.5g TID | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mesalamine granules | Drug | 3.0g mesalamine in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients still in clinical remission at the final/withdrawal examination, with clinical relapse defined as a CAI >4 with an increase of ≥3 points from baseline. | week 52 or premature withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Time to relapse | within 52 weeks | |
| Proportion of patients in endoscopical remission, defined as a mucosal appearance score of ≤ 1 at final/withdrawal examination. | week 52 or premature withdrawal |
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Inclusion Criteria:
Clinical Activity Index (CAI) <= 4, and Endoscopic Index (EI) < 4,
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Mueller, Dr. | Dr. Falk Pharma GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evangelisches Krankenhaus Kalk, Medical Dept. | Cologne | 51103 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21138455 | Result | Kruis W, Jonaitis L, Pokrotnieks J, Mikhailova TL, Horynski M, Batovsky M, Lozynsky YS, Zakharash Y, Racz I, Kull K, Vcev A, Faszczyk M, Dilger K, Greinwald R, Mueller R; International Salofalk OD Study Group. Randomised clinical trial: a comparative dose-finding study of three arms of dual release mesalazine for maintaining remission in ulcerative colitis. Aliment Pharmacol Ther. 2011 Feb;33(3):313-22. doi: 10.1111/j.1365-2036.2010.04537.x. Epub 2010 Dec 8. |
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| mesalamine granules | Drug | 1.5g mesalamine and 1.5g placebo in the morning, 0.5g placebo at lunch, 0.5g placebo in the evening; |
|
|
| mesalamine granules | Drug | 0.5g mesalamine and 2.5g placebo in the morning, 0.5g mesalamine at lunch, 0.5g mesalamine in the evening |
|
|
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| 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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