Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

Last updated: May 18, 2011
Sponsor: Ferring Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Ulcerative Colitis

Colic

Ulcers

Treatment

N/A

Clinical Study ID

NCT00209300
FE999907 CS003
2004-004565-15
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients have an established diagnosis of ulcerative colitis and are in clinicalremission with an UC-DAI < 2 at enrollment

  2. Extension of the disease > 15 cm distance from anal verge

  3. Patients who have had a clinical relapse within the past year. Clinical relapse isdefined as activity of the disease for which maintenance therapy had to be adjusted.

  4. Patients on oral mesalazine maintenance therapy ≤ 2.5 grams per day

  5. 18 years or older

  6. Signed informed consent

Exclusion

Exclusion Criteria:

  1. Patients with evidence of other forms of inflammatory bowel disease, idiopathicproctitis or infectious disease

  2. Patients allergic to acetylsalicylic acid and other salicylate derivates aspirin orsalicylates derivatives

  3. Patients who used mesalazine > 2.5 grams orally in the previous month,

  4. Patients who used rectal mesalazine > 3 grams per week in the previous month

  5. Use of corticosteroids (oral and/or rectal routes) within the last month

  6. Intake of immunosuppressants within the last 3 months

  7. 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

  8. Patients with history or physical examination findings indicative of active alcohol ordrug abuse

  9. Patients with a history of disease, including mental/emotional disorders, that wouldinterfere with their participation in the study

  10. Women who are pregnant or nursing (non-menopausal women who are sexually active and donot use effective contraceptives, as judged by the investigator, must have a negativepregnancy test)

  11. Patients who participated in another clinical study in the last 3 months

  12. Patients who were previously participating in this study

  13. Patients with any other disease that may influence the study assessment, such asmalignant disease, etc.

  14. Patients who are unable to comply with any requirements of the protocol

  15. Patients who are unable to write or read local language.

Study Design

Total Participants: 362
Study Start date:
May 01, 2005
Estimated Completion Date:
June 30, 2007

Connect with a study center

  • Hôpital Erasme Unité de Recherche, Clinique Gastro-entérologie

    Bruxelles, B-1070
    Belgium

    Site Not Available

  • UMC Sint-Pieter

    Bruxelles, B-1000
    Belgium

    Site Not Available

  • UZ Gent

    Gent, B-9000
    Belgium

    Site Not Available

  • UZ Gasthuisberg

    Leuven, B-3000
    Belgium

    Site Not Available

  • CHR de la Citadelle

    Liège, B-4000
    Belgium

    Site Not Available

  • CHR de la Citadelle

    Liège, B-4000
    Belgium

    Site Not Available

  • Heilig Hart Ziekenhuis

    Roeselaere, B-8800
    Belgium

    Site Not Available

  • AZ St. Augustinus

    Wilrijk, B-2610
    Belgium

    Site Not Available

  • Internal department Hospital Tábor

    Jaroše, 390 03
    Czech Republic

    Site Not Available

  • Internal department Hospital Tábor

    Jaroše, 390 03
    Czech Republic

    Site Not Available

  • Internal department, Hospital Jičín

    Jičín, 506 43
    Czech Republic

    Site Not Available

  • Internal department, Hospital Jičín

    Jičín, 506 43
    Czech Republic

    Site Not Available

  • Internal department Hospital Chomutov

    Kochova, 430 12
    Czech Republic

    Site Not Available

  • Hospital Mladá Boleslav - Internal Department

    Mladá Boleslav, 293 50
    Czech Republic

    Site Not Available

  • Hospital Mladá Boleslav - Internal Department

    Mladá Boleslav, 293 50
    Czech Republic

    Site Not Available

  • Gastroenterologie MUDr.V.Abrahámová

    Poděbrady, 290 01
    Czech Republic

    Site Not Available

  • Gastroenterologie MUDr.V.Abrahámová

    Poděbrady, 290 01
    Czech Republic

    Site Not Available

  • Gastroenterological Centre, University Hospital of Charles University

    Prague 2, 120 00
    Czech Republic

    Site Not Available

  • Internal department University Hospital Na Bulovce

    Prague 8, 180 00
    Czech Republic

    Site Not Available

  • Internal department, Hospital of Merciful sisters

    Praha, 101 00
    Czech Republic

    Site Not Available

  • EGK s.r.o, Gastroenterology

    Praha 3, 130 00
    Czech Republic

    Site Not Available

  • Internal department Hospital

    Příbram, 261 95
    Czech Republic

    Site Not Available

  • Internal department Hospital

    Příbram, 261 95
    Czech Republic

    Site Not Available

  • Amager Hospital Medicinsk Center

    Copenhagen S, 2300
    Denmark

    Site Not Available

  • Amtsygehuset i Gentofte

    Hellerup, 2900
    Denmark

    Site Not Available

  • Helsingor Sygehus

    Helsingor, 3000
    Denmark

    Site Not Available

  • Sygehus Vendsyssel

    Hjørring, 9800
    Denmark

    Site Not Available

  • Sygehus Vendsyssel

    Hjørring, 9800
    Denmark

    Site Not Available

  • Naestved Sygehys

    Naestved, 4700
    Denmark

    Site Not Available

  • Sonderborg Sygehus

    Soenderborg, 6400
    Denmark

    Site Not Available

  • Vejle Sygehus

    Vejle, 7100
    Denmark

    Site Not Available

  • Viborg Sygehus

    Viborg, 8800
    Denmark

    Site Not Available

  • North Karelia Central Hospital

    Joensuu, 80210
    Finland

    Site Not Available

  • Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein

    Augsburg, 86150
    Germany

    Site Not Available

  • Kreiskrankenhaus Beeskow

    Beeskow, 15848
    Germany

    Site Not Available

  • Gemeinschaftspraxis

    Berlin, 10367
    Germany

    Site Not Available

  • Praxisgemeinschaft für Innere Med./Gastro Dres. med M.-E. v. Gynz-Rekowski & R. Drossel

    Berlin, 12619
    Germany

    Site Not Available

  • Universitätsklinikum Charité, Campus Virchow Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • St. Josef-Hospital

    Bochum, 44791
    Germany

    Site Not Available

  • Universitätsklinikum Carl-Gustav-Carus, Medizinische Klinik und Poliklinik I

    Bonn, 53173
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dres. Landry, Wilhelm, Bourgeois, Pfeifer, Leibold-Lamprecht, Kindermann, Müller

    Dachau, 85221
    Germany

    Site Not Available

  • Gemeinschaftspraxis

    Dinkelsbühl, 91550
    Germany

    Site Not Available

  • Gemeinschaftspraxis

    Dinkelsbühl, 91550
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dres. Weber/Berghaus

    Dortmund, 44139
    Germany

    Site Not Available

  • Universitätsklinikum Carl-Gustav-Carus, Medizinische Klinik und Poliklinik I

    Dresden, 1307
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dres. Zeus/Schenk

    Erlangen, 91052
    Germany

    Site Not Available

  • Medizinische Klinik 1, Frankfurter Diakonie-Kliniken, Markus Krankenhaus

    Frankfurt a.M., 60431
    Germany

    Site Not Available

  • Facharzt für Innere Medizin / Gastroenterologie

    Görlitz, 2827
    Germany

    Site Not Available

  • Facharzt für Innere Medizin / Gastroenterologie

    Görlitz, 2827
    Germany

    Site Not Available

  • Gemeinschaftspraxis

    Hamburg, 20148
    Germany

    Site Not Available

  • Med. Hochschule Hannover, Zentrum Innere Medizin

    Hannover, 30625
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein

    Hof, 95028
    Germany

    Site Not Available

  • Gemeinschaftspraxis

    Homberg/Efze, 34576
    Germany

    Site Not Available

  • Gastroenterologische Gemeinschaftspraxis Dres. Lütke/Weismüller

    Koblenz, 56068
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dres. Toermer / Boedler

    Köln, 50767
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dres. Toermer / Boedler

    Köln, 50767
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dres. Dietel/Klugmann

    Leipzig, 4105
    Germany

    Site Not Available

  • Klinikum Leverkusen Medizinische Klinik 2

    Leverkusen, 51375
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dres. Kocjan / Muser

    Luedenscheid, 58507
    Germany

    Site Not Available

  • Universitätsklinikum Charité

    Magdeburg, 39114
    Germany

    Site Not Available

  • Gemeinschaftspraxis

    Mainz, 55116
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dres. Bokemeyer/Roggel/Kamp

    Minden, 32423
    Germany

    Site Not Available

  • Praxisklinik Dr. Eimiller/Prof. Kellner

    München, 80335
    Germany

    Site Not Available

  • Klinkum rechts der Isar der TUM

    München, 81675
    Germany

    Site Not Available

  • Praxisklinik Dr. Eimiller/Prof. Kellner

    München, 80335
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dres. Kardalinos/Petry

    Stuhr / Brinkum, 28816
    Germany

    Site Not Available

  • Academisch Medisch Centrum

    Amsterdam, 1100 DD
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede, 7511 JX
    Netherlands

    Site Not Available

  • Ziekenhuisgroep Twente, loc. streekziekenhuis Midden-Twente

    Hengelo, 7555 DL
    Netherlands

    Site Not Available

  • Isala klinieken

    JW Zwolle, 8011
    Netherlands

    Site Not Available

  • Ikazia ziekenhuis

    Rotterdam, 3083 AN
    Netherlands

    Site Not Available

  • Aker universitetssykehus HF

    Oslo, 0514
    Norway

    Site Not Available

  • Ullevål Universitetssykehus HF

    Oslo, 0407
    Norway

    Site Not Available

  • Centralsjukhuseet Kristianstad Medicinkliniken

    Kristianstad, 291 85
    Sweden

    Site Not Available

  • Ljungby Lasarett

    Ljungby,
    Sweden

    Site Not Available

  • Endoskopienheten Lakarhuset Hoterget

    Stockholm, 111 57
    Sweden

    Site Not Available

  • Karolinska Universitetssjukhuset

    Stockholm, 171 76
    Sweden

    Site Not Available

  • Södersjukhuset SöS Medicinkliniken

    Stockholm, 118 83
    Sweden

    Site Not Available

  • Täby Närsjukhus

    Täby, 183 36
    Sweden

    Site Not Available

  • Täby Närsjukhus

    Täby, 183 36
    Sweden

    Site Not Available

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