Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT00209300
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
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):
* 360 patients for demonstration of non-inferiority between once daily and twice daily;
* 326 to be analysed in per-protocol (PP) analyses; and
* 360 in intention-to-treat (ITT) analyses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 362
- Patients have an established diagnosis of ulcerative colitis and are in clinical remission with an UC-DAI < 2 at enrollment
- Extension of the disease > 15 cm distance from anal verge
- Patients who have had a clinical relapse within the past year. Clinical relapse is defined as activity of the disease for which maintenance therapy had to be adjusted.
- Patients on oral mesalazine maintenance therapy ≤ 2.5 grams per day
- 18 years or older
- Signed informed consent
- Patients with evidence of other forms of inflammatory bowel disease, idiopathic proctitis or infectious disease
- Patients allergic to acetylsalicylic acid and other salicylate derivates aspirin or salicylates derivatives
- Patients who used mesalazine > 2.5 grams orally in the previous month,
- Patients who used rectal mesalazine > 3 grams per week in the previous month
- Use of corticosteroids (oral and/or rectal routes) within the last month
- Intake of immunosuppressants within the last 3 months
- Patients with (known) significant hepatic (up to 2 x upper limit of normal) or (known) renal function abnormalities, to 1.5 x upper limit of normal values
- Patients with history or physical examination findings indicative of active alcohol or drug abuse
- Patients with a history of disease, including mental/emotional disorders, that would interfere with their participation in the study
- Women who are pregnant or nursing (non-menopausal women who are sexually active and do not use effective contraceptives, as judged by the investigator, must have a negative pregnancy test)
- Patients who participated in another clinical study in the last 3 months
- Patients who were previously participating in this study
- Patients with any other disease that may influence the study assessment, such as malignant disease, etc.
- Patients who are unable to comply with any requirements of the protocol
- Patients who are unable to write or read local language.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (62)
UZ Gent
🇧🇪Gent, Belgium
Heilig Hart Ziekenhuis
🇧🇪Roeselaere, Belgium
Gastroenterologie MUDr.V.Abrahámová
🇨🇿Poděbrady, Czech Republic
Hôpital Erasme Unité de Recherche, Clinique Gastro-entérologie
🇧🇪Bruxelles, Belgium
Isala klinieken
🇳🇱JW Zwolle, Netherlands
Vejle Sygehus
🇩🇰Vejle, Denmark
Gemeinschaftspraxis Dres. Zeus/Schenk
🇩🇪Erlangen, Germany
Gastroenterologische Gemeinschaftspraxis Dres. Lütke/Weismüller
🇩🇪Koblenz, Germany
Universitätsklinikum Charité
🇩🇪Magdeburg, Germany
St. Josef-Hospital
🇩🇪Bochum, Germany
CHR de la Citadelle
🇧🇪Liège, Belgium
AZ St. Augustinus
🇧🇪Wilrijk, Belgium
Internal department Hospital Tábor
🇨🇿Jaroše, Czech Republic
Gastroenterological Centre, University Hospital of Charles University
🇨🇿Prague 2, Czech Republic
Aker universitetssykehus HF
🇳🇴Oslo, Norway
Ikazia ziekenhuis
🇳🇱Rotterdam, Netherlands
Helsingor Sygehus
🇩🇰Helsingor, Denmark
Viborg Sygehus
🇩🇰Viborg, Denmark
Facharzt für Innere Medizin / Gastroenterologie
🇩🇪Görlitz, Germany
Gemeinschaftspraxis
🇩🇪Mainz, Germany
Gemeinschaftspraxis Dres. Toermer / Boedler
🇩🇪Köln, Germany
Klinikum Leverkusen Medizinische Klinik 2
🇩🇪Leverkusen, Germany
UMC Sint-Pieter
🇧🇪Bruxelles, Belgium
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Internal department, Hospital Jičín
🇨🇿Jičín, Czech Republic
Sonderborg Sygehus
🇩🇰Soenderborg, Denmark
Med. Hochschule Hannover, Zentrum Innere Medizin
🇩🇪Hannover, Germany
North Karelia Central Hospital
🇫🇮Joensuu, Finland
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Amtsygehuset i Gentofte
🇩🇰Hellerup, Denmark
Sygehus Vendsyssel
🇩🇰Hjørring, Denmark
Naestved Sygehys
🇩🇰Naestved, Denmark
Gemeinschaftspraxis Dres. Kardalinos/Petry
🇩🇪Stuhr / Brinkum, Germany
Universitätsklinikum Charité, Campus Virchow Klinikum
🇩🇪Berlin, Germany
Gemeinschaftspraxis Dres. Landry, Wilhelm, Bourgeois, Pfeifer, Leibold-Lamprecht, Kindermann, Müller
🇩🇪Dachau, Germany
Gemeinschaftspraxis Dres. Weber/Berghaus
🇩🇪Dortmund, Germany
Gemeinschaftspraxis Dres. Dietel/Klugmann
🇩🇪Leipzig, Germany
Gemeinschaftspraxis Dres. Bokemeyer/Roggel/Kamp
🇩🇪Minden, Germany
Kreiskrankenhaus Beeskow
🇩🇪Beeskow, Germany
Ullevål Universitetssykehus HF
🇳🇴Oslo, Norway
Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein
🇩🇪Hof, Germany
Universitätsklinikum Carl-Gustav-Carus, Medizinische Klinik und Poliklinik I
🇩🇪Dresden, Germany
Medizinische Klinik 1, Frankfurter Diakonie-Kliniken, Markus Krankenhaus
🇩🇪Frankfurt a.M., Germany
Praxisklinik Dr. Eimiller/Prof. Kellner
🇩🇪München, Germany
Gemeinschaftspraxis Dres. Kocjan / Muser
🇩🇪Luedenscheid, Germany
Klinkum rechts der Isar der TUM
🇩🇪München, Germany
Ljungby Lasarett
🇸🇪Ljungby, Sweden
Endoskopienheten Lakarhuset Hoterget
🇸🇪Stockholm, Sweden
Internal department Hospital Chomutov
🇨🇿Kochova, Czech Republic
Södersjukhuset SöS Medicinkliniken
🇸🇪Stockholm, Sweden
Täby Närsjukhus
🇸🇪Täby, Sweden
Amager Hospital Medicinsk Center
🇩🇰Copenhagen S, Denmark
Hospital Mladá Boleslav - Internal Department
🇨🇿Mladá Boleslav, Czech Republic
EGK s.r.o, Gastroenterology
🇨🇿Praha 3, Czech Republic
Internal department, Hospital of Merciful sisters
🇨🇿Praha, Czech Republic
Internal department Hospital
🇨🇿Příbram, Czech Republic
Praxisgemeinschaft für Innere Med./Gastro Dres. med M.-E. v. Gynz-Rekowski & R. Drossel
🇩🇪Berlin, Germany
Ziekenhuisgroep Twente, loc. streekziekenhuis Midden-Twente
🇳🇱Hengelo, Netherlands
Centralsjukhuseet Kristianstad Medicinkliniken
🇸🇪Kristianstad, Sweden
Karolinska Universitetssjukhuset
🇸🇪Stockholm, Sweden
Internal department University Hospital Na Bulovce
🇨🇿Prague 8, Czech Republic