Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00209300
• Other study ID #: FE999907 CS003
• Secondary ID: 2004-004565-15
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: May 18, 2011
• Start date: May 2005
• Est. completion date: June 2007

Study information

• Verified date: May 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesNetherlands: Medicines Evaluation Board (MEB)Norway: Norwegian Medicines AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: June 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Pentasa

Locations

Country	Name	City	State
Belgium	Hôpital Erasme Unité de Recherche, Clinique Gastro-entérologie	Bruxelles
Belgium	UMC Sint-Pieter	Bruxelles
Belgium	UZ Gent	Gent
Belgium	UZ Gasthuisberg	Leuven
Belgium	CHR de la Citadelle	Liège
Belgium	Heilig Hart Ziekenhuis	Roeselaere
Belgium	AZ St. Augustinus	Wilrijk
Czech Republic	Internal department Hospital Tábor	Jaroše
Czech Republic	Internal department, Hospital Jicín	Jicín
Czech Republic	Internal department Hospital Chomutov	Kochova
Czech Republic	Hospital Mladá Boleslav - Internal Department	Mladá Boleslav
Czech Republic	Gastroenterologie MUDr.V.Abrahámová	Podebrady
Czech Republic	Gastroenterological Centre, University Hospital of Charles University	Prague 2
Czech Republic	Internal department University Hospital Na Bulovce	Prague 8
Czech Republic	Internal department, Hospital of Merciful sisters	Praha
Czech Republic	EGK s.r.o, Gastroenterology	Praha 3
Czech Republic	Internal department Hospital	Príbram
Denmark	Amager Hospital Medicinsk Center	Copenhagen S
Denmark	Amtsygehuset i Gentofte	Hellerup
Denmark	Helsingor Sygehus	Helsingor
Denmark	Sygehus Vendsyssel	Hjørring
Denmark	Naestved Sygehys	Naestved
Denmark	Sonderborg Sygehus	Soenderborg
Denmark	Vejle Sygehus	Vejle
Denmark	Viborg Sygehus	Viborg
Finland	North Karelia Central Hospital	Joensuu
Germany	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. 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	Hannover
Germany	Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein	Hof
Germany	Gemeinschaftspraxis	Homberg/Efze
Germany	Gastroenterologische Gemeinschaftspraxis Dres. Lütke/Weismüller	Koblenz
Germany	Gemeinschaftspraxis Dres. Toermer / Boedler	Köln
Germany	Gemeinschaftspraxis Dres. Dietel/Klugmann	Leipzig
Germany	Klinikum Leverkusen Medizinische Klinik 2	Leverkusen
Germany	Gemeinschaftspraxis Dres. Kocjan / Muser	Luedenscheid
Germany	Universitätsklinikum Charité	Magdeburg
Germany	Gemeinschaftspraxis	Mainz
Germany	Gemeinschaftspraxis Dres. Bokemeyer/Roggel/Kamp	Minden
Germany	Klinkum rechts der Isar der TUM	München
Germany	Praxisklinik Dr. Eimiller/Prof. Kellner	München
Germany	Gemeinschaftspraxis Dres. Kardalinos/Petry	Stuhr / Brinkum
Netherlands	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
Norway	Aker universitetssykehus HF	Oslo
Norway	Ullevål Universitetssykehus HF	Oslo
Sweden	Centralsjukhuseet Kristianstad Medicinkliniken	Kristianstad
Sweden	Ljungby Lasarett	Ljungby
Sweden	Endoskopienheten Lakarhuset Hoterget	Stockholm
Sweden	Karolinska Universitetssjukhuset	Stockholm
Sweden	Södersjukhuset SöS Medicinkliniken	Stockholm
Sweden	Täby Närsjukhus	Täby

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Denmark,  Finland,  Germany,  Netherlands,  Norway,  Sweden,