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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2008-004610-27 | Registry Identifier | Eudra CT |
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The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dersalazine | Experimental |
| |
| Mesalazine | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dersalazine sodium | Drug | Dersalazine sodium 2400 mg daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal | 7, 14, 21, 28, 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mayo index | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julian Panés, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site 11 | Kortrijk | Belgium | ||||
| Investigational site 1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25192498 | Derived | Pontes C, Vives R, Torres F, Panes J. Safety and activity of dersalazine sodium in patients with mild-to-moderate active colitis: double-blind randomized proof of concept study. Inflamm Bowel Dis. 2014 Nov;20(11):2004-12. doi: 10.1097/MIB.0000000000000166. | |
| 22605655 | Derived | Roman J, Planell N, Lozano JJ, Aceituno M, Esteller M, Pontes C, Balsa D, Merlos M, Panes J, Salas A. Evaluation of responsive gene expression as a sensitive and specific biomarker in patients with ulcerative colitis. Inflamm Bowel Dis. 2013 Feb;19(2):221-9. doi: 10.1002/ibd.23020. |
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| Mesalazine |
| Drug |
Mesalazine 2400 mg daily |
|
| Placebo | Drug | Placebo matching active and experimental treatments |
|
| Leuven |
| Belgium |
| Investigational site 12 | Budapest | Hungary |
| Investigational site 10 | Eger | Hungary |
| Investigational site 9 | Miskolc | Hungary |
| Investigational site 8 | Székesfehérvár | Hungary |
| Investigational site 7 | Vác | Hungary |
| Investigational site 18 | Košice | Slovakia |
| Investigational site 20 | Košice | Slovakia |
| Investigational site 16 | Malacky | Slovakia |
| Investigational site 17 | Nové Zámky | Slovakia |
| Investigational site 19 | Rožňava | Slovakia |
| Investigational site 2 | Badalona | Spain |
| Investigational site 15 | Barcelona | Spain |
| Investigational site 3 | Barcelona | Spain |
| Investigational site 5 | Barcelona | Spain |
| Investigational site 21 | Cadiz | Spain |
| Investigational site 6 | Córdoba | Spain |
| Investigational site 22 | Madrid | Spain |
| Investigational site 14 | Sabadell | Spain |
| Investigational site 13 | Terrassa | Spain |
| Investigational site 4 | Terrassa | Spain |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C571878 | dersalazine |
| 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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