Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

NCT ID: NCT00209300

Last Updated: 2011-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2007-06-30

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Pentasa

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients have an established diagnosis of ulcerative colitis and are in clinical remission 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 is defined 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 Criteria

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

2. Patients allergic to acetylsalicylic acid and other salicylate derivates aspirin or salicylates 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 or drug abuse

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

10. 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)

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 as malignant 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Ferring Pharmaceuticals

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

UMC Sint-Pieter

Brussels, , Belgium

Hôpital Erasme Unité de Recherche, Clinique Gastro-entérologie

Brussels, , Belgium

UZ Gent

Ghent, , Belgium

UZ Gasthuisberg

Leuven, , Belgium

CHR de la Citadelle

Liège, , Belgium

Heilig Hart Ziekenhuis

Roeselaere, , Belgium

AZ St. Augustinus

Wilrijk, , Belgium

Internal department Hospital Tábor

Jaroše, , Czechia

Internal department, Hospital Jičín

Jičín, , Czechia

Internal department Hospital Chomutov

Kochova, , Czechia

Hospital Mladá Boleslav - Internal Department

Mladá Boleslav, , Czechia

Gastroenterologie MUDr.V.Abrahámová

Poděbrady, , Czechia

Internal department, Hospital of Merciful sisters

Prague, , Czechia

Gastroenterological Centre, University Hospital of Charles University

Prague, , Czechia

EGK s.r.o, Gastroenterology

Prague, , Czechia

Internal department University Hospital Na Bulovce

Prague, , Czechia

Internal department Hospital

Příbram, , Czechia

Amager Hospital Medicinsk Center

Copenhagen S, , Denmark

Helsingor Sygehus

Elsinore, , Denmark

Amtsygehuset i Gentofte

Hellerup, , Denmark

Sygehus Vendsyssel

Hjørring, , Denmark

Naestved Sygehys

Næstved, , Denmark

Sonderborg Sygehus

Sønderborg, , Denmark

Vejle Sygehus

Vejle, , Denmark

Viborg Sygehus

Viborg, , Denmark

North Karelia Central Hospital

Joensuu, , Finland

Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein

Augsburg, , Germany

Kreiskrankenhaus Beeskow

Beeskow, , Germany

Gemeinschaftspraxis

Berlin, , Germany

Gemeinschaftspraxis

Berlin, , Germany

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

Berlin, , Germany

Universitätsklinikum Charité, Campus Virchow Klinikum

Berlin, , Germany

St. Josef-Hospital

Bochum, , Germany

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

Bonn, , Germany

Gemeinschaftspraxis Dres. Toermer / Boedler

Cologne, , Germany

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

Dachau, , Germany

Gemeinschaftspraxis

Dinkelsbühl, , Germany

Gemeinschaftspraxis Dres. Weber/Berghaus

Dortmund, , Germany

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

Dresden, , Germany

Gemeinschaftspraxis Dres. Zeus/Schenk

Erlangen, , Germany

Medizinische Klinik 1, Frankfurter Diakonie-Kliniken, Markus Krankenhaus

Frankfurt a.M., , Germany

Facharzt für Innere Medizin / Gastroenterologie

Görlitz, , Germany

Gemeinschaftspraxis

Hamburg, , Germany

Med. Hochschule Hannover, Zentrum Innere Medizin

Hanover, , Germany

Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein

Hof, , Germany

Gemeinschaftspraxis

Homberg (Efze), , Germany

Gastroenterologische Gemeinschaftspraxis Dres. Lütke/Weismüller

Koblenz, , Germany

Gemeinschaftspraxis Dres. Dietel/Klugmann

Leipzig, , Germany

Klinikum Leverkusen Medizinische Klinik 2

Leverkusen, , Germany

Gemeinschaftspraxis Dres. Kocjan / Muser

Lüdenscheid, , Germany

Universitätsklinikum Charité

Magdeburg, , Germany

Gemeinschaftspraxis

Mainz, , Germany

Gemeinschaftspraxis Dres. Bokemeyer/Roggel/Kamp

Minden, , Germany

Praxisklinik Dr. Eimiller/Prof. Kellner

München, , Germany

Klinkum rechts der Isar der TUM

München, , Germany

Gemeinschaftspraxis Dres. Kardalinos/Petry

Stuhr / Brinkum, , Germany

Academisch Medisch Centrum

Amsterdam, , Netherlands

Medisch Spectrum Twente

Enschede, , Netherlands

Ziekenhuisgroep Twente, loc. streekziekenhuis Midden-Twente

Hengelo, , Netherlands

Isala klinieken

JW Zwolle, , Netherlands

Ikazia ziekenhuis

Rotterdam, , Netherlands

Ullevål Universitetssykehus HF

Oslo, , Norway

Aker universitetssykehus HF

Oslo, , Norway

Centralsjukhuseet Kristianstad Medicinkliniken

Kristianstad, , Sweden

Ljungby Lasarett

Ljungby, , Sweden

Endoskopienheten Lakarhuset Hoterget

Stockholm, , Sweden

Södersjukhuset SöS Medicinkliniken

Stockholm, , Sweden

Karolinska Universitetssjukhuset

Stockholm, , Sweden

Täby Närsjukhus

Täby, , Sweden

Countries

Belgium; Czechia; Denmark; Finland; Germany; Netherlands; Norway; Sweden

Other Identifiers

2004-004565-15

Identifier Type: -

Identifier Source: secondary_id

FE999907 CS003

Identifier Type: -

Identifier Source: org_study_id