Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

May 18, 2011 updated by: Ferring Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

362

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, B-1000
        • UMC Sint-Pieter
      • Bruxelles, Belgium, B-1070
        • Hôpital Erasme Unité de Recherche, Clinique Gastro-entérologie
      • Gent, Belgium, B-9000
        • UZ Gent
      • Leuven, Belgium, B-3000
        • UZ Gasthuisberg
      • Liège, Belgium, B-4000
        • CHR de la Citadelle
      • Roeselaere, Belgium, B-8800
        • Heilig Hart Ziekenhuis
      • Wilrijk, Belgium, B-2610
        • AZ St. Augustinus
  • Czech Republic
      • Jaroše, Czech Republic, 390 03
        • Internal department Hospital Tábor
      • Jičín, Czech Republic, 506 43
        • Internal department, Hospital Jičín
      • Kochova, Czech Republic, 430 12
        • Internal department Hospital Chomutov
      • Mladá Boleslav, Czech Republic, 293 50
        • Hospital Mladá Boleslav - Internal Department
      • Poděbrady, Czech Republic, 290 01
        • Gastroenterologie MUDr.V.Abrahámová
      • Prague 2, Czech Republic, 120 00
        • Gastroenterological Centre, University Hospital of Charles University
      • Prague 8, Czech Republic, 180 00
        • Internal department University Hospital Na Bulovce
      • Praha, Czech Republic, 101 00
        • Internal department, Hospital of Merciful sisters
      • Praha 3, Czech Republic, 130 00
        • EGK s.r.o, Gastroenterology
      • Příbram, Czech Republic, 261 95
        • Internal department Hospital
  • Denmark
      • Copenhagen S, Denmark, 2300
        • Amager Hospital Medicinsk Center
      • Hellerup, Denmark, 2900
        • Amtsygehuset i Gentofte
      • Helsingor, Denmark, 3000
        • Helsingor Sygehus
      • Hjørring, Denmark, 9800
        • Sygehus Vendsyssel
      • Naestved, Denmark, 4700
        • Naestved Sygehys
      • Soenderborg, Denmark, 6400
        • Sonderborg Sygehus
      • Vejle, Denmark, 7100
        • Vejle Sygehus
      • Viborg, Denmark, 8800
        • Viborg Sygehus
  • Finland
      • Joensuu, Finland, 80210
        • North Karelia Central Hospital
  • Germany
      • Augsburg, Germany, 86150
        • Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein
      • Beeskow, Germany, 15848
        • Kreiskrankenhaus Beeskow
      • Berlin, Germany, 10318
        • Gemeinschaftspraxis
      • Berlin, Germany, 10367
        • Gemeinschaftspraxis
      • Berlin, Germany, 12619
        • Praxisgemeinschaft für Innere Med./Gastro Dres. med M.-E. v. Gynz-Rekowski & R. Drossel
      • Berlin, Germany, 13353
        • Universitätsklinikum Charité, Campus Virchow Klinikum
      • Bochum, Germany, 44791
        • St. Josef-Hospital
      • Bonn, Germany, 53173
        • Universitätsklinikum Carl-Gustav-Carus, Medizinische Klinik und Poliklinik I
      • Dachau, Germany, 85221
        • Gemeinschaftspraxis Dres. Landry, Wilhelm, Bourgeois, Pfeifer, Leibold-Lamprecht, Kindermann, Müller
      • Dinkelsbühl, Germany, 91550
        • Gemeinschaftspraxis
      • Dortmund, Germany, 44139
        • Gemeinschaftspraxis Dres. Weber/Berghaus
      • Dresden, Germany, 1307
        • Universitätsklinikum Carl-Gustav-Carus, Medizinische Klinik und Poliklinik I
      • Erlangen, Germany, 91052
        • Gemeinschaftspraxis Dres. Zeus/Schenk
      • Frankfurt a.M., Germany, 60431
        • Medizinische Klinik 1, Frankfurter Diakonie-Kliniken, Markus Krankenhaus
      • Görlitz, Germany, 2827
        • Facharzt für Innere Medizin / Gastroenterologie
      • Hamburg, Germany, 20148
        • Gemeinschaftspraxis
      • Hannover, Germany, 30625
        • Med. Hochschule Hannover, Zentrum Innere Medizin
      • Hof, Germany, 95028
        • Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein
      • Homberg/Efze, Germany, 34576
        • Gemeinschaftspraxis
      • Koblenz, Germany, 56068
        • Gastroenterologische Gemeinschaftspraxis Dres. Lütke/Weismüller
      • Köln, Germany, 50767
        • Gemeinschaftspraxis Dres. Toermer / Boedler
      • Leipzig, Germany, 4105
        • Gemeinschaftspraxis Dres. Dietel/Klugmann
      • Leverkusen, Germany, 51375
        • Klinikum Leverkusen Medizinische Klinik 2
      • Luedenscheid, Germany, 58507
        • Gemeinschaftspraxis Dres. Kocjan / Muser
      • Magdeburg, Germany, 39114
        • Universitätsklinikum Charité
      • Mainz, Germany, 55116
        • Gemeinschaftspraxis
      • Minden, Germany, 32423
        • Gemeinschaftspraxis Dres. Bokemeyer/Roggel/Kamp
      • München, Germany, 80335
        • Praxisklinik Dr. Eimiller/Prof. Kellner
      • München, Germany, 81675
        • Klinkum rechts der Isar der TUM
      • Stuhr / Brinkum, Germany, 28816
        • Gemeinschaftspraxis Dres. Kardalinos/Petry
  • Netherlands
      • Amsterdam, Netherlands, 1100 DD
        • Academisch Medisch Centrum
      • Enschede, Netherlands, 7511 JX
        • Medisch Spectrum Twente
      • Hengelo, Netherlands, 7555 DL
        • Ziekenhuisgroep Twente, loc. streekziekenhuis Midden-Twente
      • JW Zwolle, Netherlands, 8011
        • Isala Klinieken
      • Rotterdam, Netherlands, 3083 AN
        • Ikazia Ziekenhuis
  • Norway
      • Oslo, Norway, 0407
        • Ullevål universitetssykehus HF
      • Oslo, Norway, 0514
        • Aker Universitetssykehus HF
  • Sweden
      • Kristianstad, Sweden, 291 85
        • Centralsjukhuseet Kristianstad Medicinkliniken
      • Ljungby, Sweden
        • Ljungby Lasarett
      • Stockholm, Sweden, 171 76
        • Karolinska Universitetssjukhuset
      • Stockholm, Sweden, 111 57
        • Endoskopienheten Lakarhuset Hoterget
      • Stockholm, Sweden, 118 83
        • Södersjukhuset SöS Medicinkliniken
      • Täby, Sweden, 183 36
        • Täby Närsjukhus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FE999907 CS003
  • 2004-004565-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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