Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

NCT00209300 | Completed Phase 3 DMC

• 2 other identifiers: FE999907 CS0032004-004565-15
• Study Type: interventional
• Target: 362
• Locations: 8 countries
• Sites: 69

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

Keywords

Ulcerative Colitis for Maintenance of Remission

Interventions

Pentasa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• Signed informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (69)

UMC Sint-Pieter

Brussels, B-1000, Belgium

Location

Hôpital Erasme Unité de Recherche, Clinique Gastro-entérologie

Brussels, B-1070, Belgium

Location

UZ Gent

Ghent, B-9000, Belgium

Location

UZ Gasthuisberg

Leuven, B-3000, Belgium

Location

CHR de la Citadelle

Liège, B-4000, Belgium

Location

Heilig Hart Ziekenhuis

Roeselaere, B-8800, Belgium

Location

AZ St. Augustinus

Wilrijk, B-2610, Belgium

Location

Internal department Hospital Tábor

Jaroše, 390 03, Czechia

Location

Internal department, Hospital Jičín

Jičín, 506 43, Czechia

Location

Internal department Hospital Chomutov

Kochova, 430 12, Czechia

Location

Hospital Mladá Boleslav - Internal Department

Mladá Boleslav, 293 50, Czechia

Location

Gastroenterologie MUDr.V.Abrahámová

Poděbrady, 290 01, Czechia

Location

Internal department, Hospital of Merciful sisters

Prague, 101 00, Czechia

Location

Gastroenterological Centre, University Hospital of Charles University

Prague, 120 00, Czechia

Location

EGK s.r.o, Gastroenterology

Prague, 130 00, Czechia

Location

Internal department University Hospital Na Bulovce

Prague, 180 00, Czechia

Location

Internal department Hospital

Příbram, 261 95, Czechia

Location

Amager Hospital Medicinsk Center

Copenhagen S, 2300, Denmark

Location

Helsingor Sygehus

Elsinore, 3000, Denmark

Location

Amtsygehuset i Gentofte

Hellerup, 2900, Denmark

Location

Sygehus Vendsyssel

Hjørring, 9800, Denmark

Location

Naestved Sygehys

Næstved, 4700, Denmark

Location

Sonderborg Sygehus

Sønderborg, 6400, Denmark

Location

Vejle Sygehus

Vejle, 7100, Denmark

Location

Viborg Sygehus

Viborg, 8800, Denmark

Location

North Karelia Central Hospital

Joensuu, 80210, Finland

Location

Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein

Augsburg, 86150, Germany

Location

Kreiskrankenhaus Beeskow

Beeskow, 15848, Germany

Location

Gemeinschaftspraxis

Berlin, 10318, Germany

Location

Gemeinschaftspraxis

Berlin, 10367, Germany

Location

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

Berlin, 12619, Germany

Location

Universitätsklinikum Charité, Campus Virchow Klinikum

Berlin, 13353, Germany

Location

St. Josef-Hospital

Bochum, 44791, Germany

Location

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

Bonn, 53173, Germany

Location

Gemeinschaftspraxis Dres. Toermer / Boedler

Cologne, 50767, Germany

Location

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

Dachau, 85221, Germany

Location

Gemeinschaftspraxis

Dinkelsbühl, 91550, Germany

Location

Gemeinschaftspraxis Dres. Weber/Berghaus

Dortmund, 44139, Germany

Location

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

Dresden, 1307, Germany

Location

Gemeinschaftspraxis Dres. Zeus/Schenk

Erlangen, 91052, Germany

Location

Medizinische Klinik 1, Frankfurter Diakonie-Kliniken, Markus Krankenhaus

Frankfurt a.M., 60431, Germany

Location

Facharzt für Innere Medizin / Gastroenterologie

Görlitz, 2827, Germany

Location

Gemeinschaftspraxis

Hamburg, 20148, Germany

Location

Med. Hochschule Hannover, Zentrum Innere Medizin

Hanover, 30625, Germany

Location

Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein

Hof, 95028, Germany

Location

Gemeinschaftspraxis

Homberg (Efze), 34576, Germany

Location

Gastroenterologische Gemeinschaftspraxis Dres. Lütke/Weismüller

Koblenz, 56068, Germany

Location

Gemeinschaftspraxis Dres. Dietel/Klugmann

Leipzig, 4105, Germany

Location

Klinikum Leverkusen Medizinische Klinik 2

Leverkusen, 51375, Germany

Location

Gemeinschaftspraxis Dres. Kocjan / Muser

Lüdenscheid, 58507, Germany

Location

Universitätsklinikum Charité

Magdeburg, 39114, Germany

Location

Gemeinschaftspraxis

Mainz, 55116, Germany

Location

Gemeinschaftspraxis Dres. Bokemeyer/Roggel/Kamp

Minden, 32423, Germany

Location

Praxisklinik Dr. Eimiller/Prof. Kellner

München, 80335, Germany

Location

Klinkum rechts der Isar der TUM

München, 81675, Germany

Location

Gemeinschaftspraxis Dres. Kardalinos/Petry

Stuhr / Brinkum, 28816, Germany

Location

Academisch Medisch Centrum

Amsterdam, 1100 DD, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7511 JX, Netherlands

Location

Ziekenhuisgroep Twente, loc. streekziekenhuis Midden-Twente

Hengelo, 7555 DL, Netherlands

Location

Isala klinieken

JW Zwolle, 8011, Netherlands

Location

Ikazia ziekenhuis

Rotterdam, 3083 AN, Netherlands

Location

Ullevål Universitetssykehus HF

Oslo, 0407, Norway

Location

Aker universitetssykehus HF

Oslo, 0514, Norway

Location

Centralsjukhuseet Kristianstad Medicinkliniken

Kristianstad, 291 85, Sweden

Location

Ljungby Lasarett

Ljungby, Sweden

Location

Endoskopienheten Lakarhuset Hoterget

Stockholm, 111 57, Sweden

Location

Södersjukhuset SöS Medicinkliniken

Stockholm, 118 83, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, 171 76, Sweden

Location

Täby Närsjukhus

Täby, 183 36, Sweden

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: June 1, 2007
• Last Updated: May 19, 2011

Record last verified: 2011-05

Locations

BE (7); CZ (10); NL (5); SE (6); DE (30); NO (2); DK (8); FI (1)