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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-004565-15 |
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This is a multi-centre, randomised, controlled, investigator blinded study. The randomisation will be done centrally. The patients will be treated for 1 year, with clinical and laboratory assessments at 0, 4, 8 and 12 months.
Endoscopic examination is at enrollment and on completion of the study (at relapse or after 12 months).
Number of Subjects (Planned and Analysed):
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentasa | Drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Sint-Pieter | Brussels | B-1000 | Belgium | |||
| Hôpital Erasme Unité de Recherche, Clinique Gastro-entérologie |
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| Brussels |
| B-1070 |
| Belgium |
| UZ Gent | Ghent | B-9000 | Belgium |
| UZ Gasthuisberg | Leuven | B-3000 | Belgium |
| CHR de la Citadelle | Liège | B-4000 | Belgium |
| Heilig Hart Ziekenhuis | Roeselaere | B-8800 | Belgium |
| AZ St. Augustinus | Wilrijk | B-2610 | Belgium |
| Internal department Hospital Tábor | Jaroše | 390 03 | Czechia |
| Internal department, Hospital Jičín | Jičín | 506 43 | Czechia |
| Internal department Hospital Chomutov | Kochova | 430 12 | Czechia |
| Hospital Mladá Boleslav - Internal Department | Mladá Boleslav | 293 50 | Czechia |
| Gastroenterologie MUDr.V.Abrahámová | Poděbrady | 290 01 | Czechia |
| Internal department, Hospital of Merciful sisters | Prague | 101 00 | Czechia |
| Gastroenterological Centre, University Hospital of Charles University | Prague | 120 00 | Czechia |
| EGK s.r.o, Gastroenterology | Prague | 130 00 | Czechia |
| Internal department University Hospital Na Bulovce | Prague | 180 00 | Czechia |
| Internal department Hospital | Příbram | 261 95 | Czechia |
| Amager Hospital Medicinsk Center | Copenhagen S | 2300 | Denmark |
| Helsingor Sygehus | Elsinore | 3000 | Denmark |
| Amtsygehuset i Gentofte | Hellerup | 2900 | Denmark |
| Sygehus Vendsyssel | Hjørring | 9800 | Denmark |
| Naestved Sygehys | Næstved | 4700 | Denmark |
| Sonderborg Sygehus | Sønderborg | 6400 | Denmark |
| Vejle Sygehus | Vejle | 7100 | Denmark |
| Viborg Sygehus | Viborg | 8800 | Denmark |
| North Karelia Central Hospital | Joensuu | 80210 | Finland |
| Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein | Augsburg | 86150 | Germany |
| Kreiskrankenhaus Beeskow | Beeskow | 15848 | Germany |
| Gemeinschaftspraxis | Berlin | 10318 | Germany |
| Gemeinschaftspraxis | Berlin | 10367 | Germany |
| Praxisgemeinschaft für Innere Med./Gastro Dres. med M.-E. v. Gynz-Rekowski & R. Drossel | Berlin | 12619 | Germany |
| Universitätsklinikum Charité, Campus Virchow Klinikum | Berlin | 13353 | Germany |
| St. Josef-Hospital | Bochum | 44791 | Germany |
| Universitätsklinikum Carl-Gustav-Carus, Medizinische Klinik und Poliklinik I | Bonn | 53173 | Germany |
| Gemeinschaftspraxis Dres. Toermer / Boedler | Cologne | 50767 | Germany |
| Gemeinschaftspraxis Dres. Landry, Wilhelm, Bourgeois, Pfeifer, Leibold-Lamprecht, Kindermann, Müller | Dachau | 85221 | Germany |
| Gemeinschaftspraxis | Dinkelsbühl | 91550 | Germany |
| Gemeinschaftspraxis Dres. Weber/Berghaus | Dortmund | 44139 | Germany |
| Universitätsklinikum Carl-Gustav-Carus, Medizinische Klinik und Poliklinik I | Dresden | 1307 | Germany |
| Gemeinschaftspraxis Dres. Zeus/Schenk | Erlangen | 91052 | Germany |
| Medizinische Klinik 1, Frankfurter Diakonie-Kliniken, Markus Krankenhaus | Frankfurt a.M. | 60431 | Germany |
| Facharzt für Innere Medizin / Gastroenterologie | Görlitz | 2827 | Germany |
| Gemeinschaftspraxis | Hamburg | 20148 | Germany |
| Med. Hochschule Hannover, Zentrum Innere Medizin | Hanover | 30625 | Germany |
| Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein | Hof | 95028 | Germany |
| Gemeinschaftspraxis | Homberg (Efze) | 34576 | Germany |
| Gastroenterologische Gemeinschaftspraxis Dres. Lütke/Weismüller | Koblenz | 56068 | Germany |
| Gemeinschaftspraxis Dres. Dietel/Klugmann | Leipzig | 4105 | Germany |
| Klinikum Leverkusen Medizinische Klinik 2 | Leverkusen | 51375 | Germany |
| Gemeinschaftspraxis Dres. Kocjan / Muser | Lüdenscheid | 58507 | Germany |
| Universitätsklinikum Charité | Magdeburg | 39114 | Germany |
| Gemeinschaftspraxis | Mainz | 55116 | Germany |
| Gemeinschaftspraxis Dres. Bokemeyer/Roggel/Kamp | Minden | 32423 | Germany |
| Praxisklinik Dr. Eimiller/Prof. Kellner | München | 80335 | Germany |
| Klinkum rechts der Isar der TUM | München | 81675 | Germany |
| Gemeinschaftspraxis Dres. Kardalinos/Petry | Stuhr / Brinkum | 28816 | Germany |
| Academisch Medisch Centrum | Amsterdam | 1100 DD | Netherlands |
| Medisch Spectrum Twente | Enschede | 7511 JX | Netherlands |
| Ziekenhuisgroep Twente, loc. streekziekenhuis Midden-Twente | Hengelo | 7555 DL | Netherlands |
| Isala klinieken | JW Zwolle | 8011 | Netherlands |
| Ikazia ziekenhuis | Rotterdam | 3083 AN | Netherlands |
| Ullevål Universitetssykehus HF | Oslo | 0407 | Norway |
| Aker universitetssykehus HF | Oslo | 0514 | Norway |
| Centralsjukhuseet Kristianstad Medicinkliniken | Kristianstad | 291 85 | Sweden |
| Ljungby Lasarett | Ljungby | Sweden |
| Endoskopienheten Lakarhuset Hoterget | Stockholm | 111 57 | Sweden |
| Södersjukhuset SöS Medicinkliniken | Stockholm | 118 83 | Sweden |
| Karolinska Universitetssjukhuset | Stockholm | 171 76 | Sweden |
| Täby Närsjukhus | Täby | 183 36 | Sweden |
| 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 |
|---|---|
| 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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