Clinical trial NCT00209300: Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission
Official title: Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once Daily
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis for Maintenance of Remission
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: UMC Sint-Pieter
city: Bruxelles
country: Belgium
facility: Hôpital Erasme Unité de Recherche, Clinique Gastro-entérologie
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Liège
country: Belgium
facility: CHR de la Citadelle
city: Roeselaere
country: Belgium
facility: Heilig Hart Ziekenhuis
city: Wilrijk
country: Belgium
facility: AZ St. Augustinus
city: Jaroše
country: Czech Republic
facility: Internal department Hospital Tábor
city: Jičín
country: Czech Republic
facility: Internal department, Hospital Jičín
city: Kochova
country: Czech Republic
facility: Internal department Hospital Chomutov
city: Mladá Boleslav
country: Czech Republic
facility: Hospital Mladá Boleslav - Internal Department
city: Poděbrady
country: Czech Republic
facility: Gastroenterologie MUDr.V.Abrahámová
city: Prague 2
country: Czech Republic
facility: Gastroenterological Centre, University Hospital of Charles University
city: Prague 8
country: Czech Republic
facility: Internal department University Hospital Na Bulovce
city: Praha 3
country: Czech Republic
facility: EGK s.r.o, Gastroenterology
city: Praha
country: Czech Republic
facility: Internal department, Hospital of Merciful sisters
city: Příbram
country: Czech Republic
facility: Internal department Hospital
city: Copenhagen S
country: Denmark
facility: Amager Hospital Medicinsk Center
city: Hellerup
country: Denmark
facility: Amtsygehuset i Gentofte
city: Helsingor
country: Denmark
facility: Helsingor Sygehus
city: Hjørring
country: Denmark
facility: Sygehus Vendsyssel
city: Naestved
country: Denmark
facility: Naestved Sygehys
city: Soenderborg
country: Denmark
facility: Sonderborg Sygehus
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Viborg
country: Denmark
facility: Viborg Sygehus
city: Joensuu
country: Finland
facility: North Karelia Central Hospital
city: Augsburg
country: Germany
facility: Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein
city: Beeskow
country: Germany
facility: Kreiskrankenhaus Beeskow
city: Berlin
country: Germany
facility: Gemeinschaftspraxis
city: Berlin
country: Germany
facility: Gemeinschaftspraxis
city: Berlin
country: Germany
facility: Praxisgemeinschaft für Innere Med./Gastro Dres. med M.-E. v. Gynz-Rekowski & R. Drossel
city: Berlin
country: Germany
facility: Universitätsklinikum Charité, Campus Virchow Klinikum
city: Bochum
country: Germany
facility: St. Josef-Hospital
city: Bonn
country: Germany
facility: Universitätsklinikum Carl-Gustav-Carus, Medizinische Klinik und Poliklinik I
city: Dachau
country: Germany
facility: Gemeinschaftspraxis Dres. Landry, Wilhelm, Bourgeois, Pfeifer, Leibold-Lamprecht, Kindermann, Müller
city: Dinkelsbühl
country: Germany
facility: Gemeinschaftspraxis
city: Dortmund
country: Germany
facility: Gemeinschaftspraxis Dres. Weber/Berghaus
city: Dresden
country: Germany
facility: Universitätsklinikum Carl-Gustav-Carus, Medizinische Klinik und Poliklinik I
city: Erlangen
country: Germany
facility: Gemeinschaftspraxis Dres. Zeus/Schenk
city: Frankfurt a.M.
country: Germany
facility: Medizinische Klinik 1, Frankfurter Diakonie-Kliniken, Markus Krankenhaus
city: Görlitz
country: Germany
facility: Facharzt für Innere Medizin / Gastroenterologie
city: Hamburg
country: Germany
facility: Gemeinschaftspraxis
city: Hannover
country: Germany
facility: Med. Hochschule Hannover, Zentrum Innere Medizin
city: Hof
country: Germany
facility: Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein
city: Homberg/Efze
country: Germany
facility: Gemeinschaftspraxis
city: Koblenz
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Dres. Lütke/Weismüller
city: Köln
country: Germany
facility: Gemeinschaftspraxis Dres. Toermer / Boedler
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis Dres. Dietel/Klugmann
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen Medizinische Klinik 2
city: Luedenscheid
country: Germany
facility: Gemeinschaftspraxis Dres. Kocjan / Muser
city: Magdeburg
country: Germany
facility: Universitätsklinikum Charité
city: Mainz
country: Germany
facility: Gemeinschaftspraxis
city: Minden
country: Germany
facility: Gemeinschaftspraxis Dres. Bokemeyer/Roggel/Kamp
city: München
country: Germany
facility: Praxisklinik Dr. Eimiller/Prof. Kellner
city: München
country: Germany
facility: Klinkum rechts der Isar der TUM
city: Stuhr / Brinkum
country: Germany
facility: Gemeinschaftspraxis Dres. Kardalinos/Petry
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Hengelo
country: Netherlands
facility: Ziekenhuisgroep Twente, loc. streekziekenhuis Midden-Twente
city: JW Zwolle
country: Netherlands
facility: Isala klinieken
city: Rotterdam
country: Netherlands
facility: Ikazia ziekenhuis
city: Oslo
country: Norway
facility: Ullevål Universitetssykehus HF
city: Oslo
country: Norway
facility: Aker universitetssykehus HF
city: Kristianstad
country: Sweden
facility: Centralsjukhuseet Kristianstad Medicinkliniken
city: Ljungby
country: Sweden
facility: Ljungby Lasarett
city: Stockholm
country: Sweden
facility: Endoskopienheten Lakarhuset Hoterget
city: Stockholm
country: Sweden
facility: Södersjukhuset SöS Medicinkliniken
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Täby
country: Sweden
facility: Täby Närsjukhus
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: