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Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pentasa
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ulcerative Colitis focused on measuring Ulcerative Colitis for Maintenance of Remission

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 18 years or older Signed informed consent Exclusion Criteria: 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.

Sites / Locations

  • UMC Sint-Pieter
  • Hôpital Erasme Unité de Recherche, Clinique Gastro-entérologie
  • UZ Gent
  • UZ Gasthuisberg
  • CHR de la Citadelle
  • Heilig Hart Ziekenhuis
  • AZ St. Augustinus
  • Internal department Hospital Tábor
  • Internal department, Hospital Jičín
  • Internal department Hospital Chomutov
  • Hospital Mladá Boleslav - Internal Department
  • Gastroenterologie MUDr.V.Abrahámová
  • Gastroenterological Centre, University Hospital of Charles University
  • Internal department University Hospital Na Bulovce
  • EGK s.r.o, Gastroenterology
  • Internal department, Hospital of Merciful sisters
  • Internal department Hospital
  • Amager Hospital Medicinsk Center
  • Amtsygehuset i Gentofte
  • Helsingor Sygehus
  • Sygehus Vendsyssel
  • Naestved Sygehys
  • Sonderborg Sygehus
  • Vejle Sygehus
  • Viborg Sygehus
  • North Karelia Central Hospital
  • Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein
  • Kreiskrankenhaus Beeskow
  • Gemeinschaftspraxis
  • Gemeinschaftspraxis
  • Praxisgemeinschaft für Innere Med./Gastro Dres. med M.-E. v. Gynz-Rekowski & R. Drossel
  • Universitätsklinikum Charité, Campus Virchow Klinikum
  • St. Josef-Hospital
  • Universitätsklinikum Carl-Gustav-Carus, Medizinische Klinik und Poliklinik I
  • Gemeinschaftspraxis Dres. Landry, Wilhelm, Bourgeois, Pfeifer, Leibold-Lamprecht, Kindermann, Müller
  • Gemeinschaftspraxis
  • Gemeinschaftspraxis Dres. Weber/Berghaus
  • Universitätsklinikum Carl-Gustav-Carus, Medizinische Klinik und Poliklinik I
  • Gemeinschaftspraxis Dres. Zeus/Schenk
  • Medizinische Klinik 1, Frankfurter Diakonie-Kliniken, Markus Krankenhaus
  • Facharzt für Innere Medizin / Gastroenterologie
  • Gemeinschaftspraxis
  • Med. Hochschule Hannover, Zentrum Innere Medizin
  • Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein
  • Gemeinschaftspraxis
  • Gastroenterologische Gemeinschaftspraxis Dres. Lütke/Weismüller
  • Gemeinschaftspraxis Dres. Toermer / Boedler
  • Gemeinschaftspraxis Dres. Dietel/Klugmann
  • Klinikum Leverkusen Medizinische Klinik 2
  • Gemeinschaftspraxis Dres. Kocjan / Muser
  • Universitätsklinikum Charité
  • Gemeinschaftspraxis
  • Gemeinschaftspraxis Dres. Bokemeyer/Roggel/Kamp
  • Praxisklinik Dr. Eimiller/Prof. Kellner
  • Klinkum rechts der Isar der TUM
  • Gemeinschaftspraxis Dres. Kardalinos/Petry
  • Academisch Medisch Centrum
  • Medisch Spectrum Twente
  • Ziekenhuisgroep Twente, loc. streekziekenhuis Midden-Twente
  • Isala klinieken
  • Ikazia ziekenhuis
  • Ullevål Universitetssykehus HF
  • Aker universitetssykehus HF
  • Centralsjukhuseet Kristianstad Medicinkliniken
  • Ljungby Lasarett
  • Endoskopienheten Lakarhuset Hoterget
  • Södersjukhuset SöS Medicinkliniken
  • Karolinska Universitetssjukhuset
  • Täby Närsjukhus

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
May 18, 2011
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00209300
Brief Title
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

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis for Maintenance of Remission

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
362 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pentasa

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 18 years or older Signed informed consent Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
UMC Sint-Pieter
City
Bruxelles
ZIP/Postal Code
B-1000
Country
Belgium
Facility Name
Hôpital Erasme Unité de Recherche, Clinique Gastro-entérologie
City
Bruxelles
ZIP/Postal Code
B-1070
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liège
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
Heilig Hart Ziekenhuis
City
Roeselaere
ZIP/Postal Code
B-8800
Country
Belgium
Facility Name
AZ St. Augustinus
City
Wilrijk
ZIP/Postal Code
B-2610
Country
Belgium
Facility Name
Internal department Hospital Tábor
City
Jaroše
ZIP/Postal Code
390 03
Country
Czech Republic
Facility Name
Internal department, Hospital Jičín
City
Jičín
ZIP/Postal Code
506 43
Country
Czech Republic
Facility Name
Internal department Hospital Chomutov
City
Kochova
ZIP/Postal Code
430 12
Country
Czech Republic
Facility Name
Hospital Mladá Boleslav - Internal Department
City
Mladá Boleslav
ZIP/Postal Code
293 50
Country
Czech Republic
Facility Name
Gastroenterologie MUDr.V.Abrahámová
City
Poděbrady
ZIP/Postal Code
290 01
Country
Czech Republic
Facility Name
Gastroenterological Centre, University Hospital of Charles University
City
Prague 2
ZIP/Postal Code
120 00
Country
Czech Republic
Facility Name
Internal department University Hospital Na Bulovce
City
Prague 8
ZIP/Postal Code
180 00
Country
Czech Republic
Facility Name
EGK s.r.o, Gastroenterology
City
Praha 3
ZIP/Postal Code
130 00
Country
Czech Republic
Facility Name
Internal department, Hospital of Merciful sisters
City
Praha
ZIP/Postal Code
101 00
Country
Czech Republic
Facility Name
Internal department Hospital
City
Příbram
ZIP/Postal Code
261 95
Country
Czech Republic
Facility Name
Amager Hospital Medicinsk Center
City
Copenhagen S
ZIP/Postal Code
2300
Country
Denmark
Facility Name
Amtsygehuset i Gentofte
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Helsingor Sygehus
City
Helsingor
ZIP/Postal Code
3000
Country
Denmark
Facility Name
Sygehus Vendsyssel
City
Hjørring
ZIP/Postal Code
9800
Country
Denmark
Facility Name
Naestved Sygehys
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Sonderborg Sygehus
City
Soenderborg
ZIP/Postal Code
6400
Country
Denmark
Facility Name
Vejle Sygehus
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Viborg Sygehus
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
North Karelia Central Hospital
City
Joensuu
ZIP/Postal Code
80210
Country
Finland
Facility Name
Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Kreiskrankenhaus Beeskow
City
Beeskow
ZIP/Postal Code
15848
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Berlin
ZIP/Postal Code
10318
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Praxisgemeinschaft für Innere Med./Gastro Dres. med M.-E. v. Gynz-Rekowski & R. Drossel
City
Berlin
ZIP/Postal Code
12619
Country
Germany
Facility Name
Universitätsklinikum Charité, Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
St. Josef-Hospital
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universitätsklinikum Carl-Gustav-Carus, Medizinische Klinik und Poliklinik I
City
Bonn
ZIP/Postal Code
53173
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Landry, Wilhelm, Bourgeois, Pfeifer, Leibold-Lamprecht, Kindermann, Müller
City
Dachau
ZIP/Postal Code
85221
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Dinkelsbühl
ZIP/Postal Code
91550
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Weber/Berghaus
City
Dortmund
ZIP/Postal Code
44139
Country
Germany
Facility Name
Universitätsklinikum Carl-Gustav-Carus, Medizinische Klinik und Poliklinik I
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Zeus/Schenk
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Facility Name
Medizinische Klinik 1, Frankfurter Diakonie-Kliniken, Markus Krankenhaus
City
Frankfurt a.M.
ZIP/Postal Code
60431
Country
Germany
Facility Name
Facharzt für Innere Medizin / Gastroenterologie
City
Görlitz
ZIP/Postal Code
2827
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Hamburg
ZIP/Postal Code
20148
Country
Germany
Facility Name
Med. Hochschule Hannover, Zentrum Innere Medizin
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein
City
Hof
ZIP/Postal Code
95028
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Homberg/Efze
ZIP/Postal Code
34576
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Dres. Lütke/Weismüller
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Toermer / Boedler
City
Köln
ZIP/Postal Code
50767
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Dietel/Klugmann
City
Leipzig
ZIP/Postal Code
4105
Country
Germany
Facility Name
Klinikum Leverkusen Medizinische Klinik 2
City
Leverkusen
ZIP/Postal Code
51375
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Kocjan / Muser
City
Luedenscheid
ZIP/Postal Code
58507
Country
Germany
Facility Name
Universitätsklinikum Charité
City
Magdeburg
ZIP/Postal Code
39114
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Bokemeyer/Roggel/Kamp
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Praxisklinik Dr. Eimiller/Prof. Kellner
City
München
ZIP/Postal Code
80335
Country
Germany
Facility Name
Klinkum rechts der Isar der TUM
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Kardalinos/Petry
City
Stuhr / Brinkum
ZIP/Postal Code
28816
Country
Germany
Facility Name
Academisch Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
ZIP/Postal Code
7511 JX
Country
Netherlands
Facility Name
Ziekenhuisgroep Twente, loc. streekziekenhuis Midden-Twente
City
Hengelo
ZIP/Postal Code
7555 DL
Country
Netherlands
Facility Name
Isala klinieken
City
JW Zwolle
ZIP/Postal Code
8011
Country
Netherlands
Facility Name
Ikazia ziekenhuis
City
Rotterdam
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
Ullevål Universitetssykehus HF
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Aker universitetssykehus HF
City
Oslo
ZIP/Postal Code
0514
Country
Norway
Facility Name
Centralsjukhuseet Kristianstad Medicinkliniken
City
Kristianstad
ZIP/Postal Code
291 85
Country
Sweden
Facility Name
Ljungby Lasarett
City
Ljungby
Country
Sweden
Facility Name
Endoskopienheten Lakarhuset Hoterget
City
Stockholm
ZIP/Postal Code
111 57
Country
Sweden
Facility Name
Södersjukhuset SöS Medicinkliniken
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Täby Närsjukhus
City
Täby
ZIP/Postal Code
183 36
Country
Sweden

12. IPD Sharing Statement

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Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

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