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Ulcerative ColitisPhase 3NCT00209300

Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

A Phase 3 study testing Pentasa in people with Ulcerative Colitis, run by Ferring Pharmaceuticals at 69 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
Pentasa
How many people
362 participants
Where
69 sitesin 8 countries
Study dates
May 2005to Jun 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

69 sites in 8 countries.

69 sites in 8 countries

Germany30 sites

  • Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein

    Augsburg, 86150

  • Kreiskrankenhaus Beeskow

    Beeskow, 15848

  • Gemeinschaftspraxis

    Berlin, 10318

  • Gemeinschaftspraxis

    Berlin, 10367

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

    Berlin, 12619

  • Universitätsklinikum Charité, Campus Virchow Klinikum

    Berlin, 13353

  • St. Josef-Hospital

    Bochum, 44791

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

    Bonn, 53173

  • Gemeinschaftspraxis Dres. Toermer / Boedler

    Cologne, 50767

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

    Dachau, 85221

  • Gemeinschaftspraxis

    Dinkelsbühl, 91550

  • Gemeinschaftspraxis Dres. Weber/Berghaus

    Dortmund, 44139

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

    Dresden, 1307

  • Gemeinschaftspraxis Dres. Zeus/Schenk

    Erlangen, 91052

  • Medizinische Klinik 1, Frankfurter Diakonie-Kliniken, Markus Krankenhaus

    Frankfurt a.M., 60431

  • Facharzt für Innere Medizin / Gastroenterologie

    Görlitz, 2827

  • Gemeinschaftspraxis

    Hamburg, 20148

  • Med. Hochschule Hannover, Zentrum Innere Medizin

    Hanover, 30625

  • Gemeinschaftspraxis Dres. Lupberger, Kraus, Graf Finck von Finckenstein

    Hof, 95028

  • Gemeinschaftspraxis

    Homberg (Efze), 34576

  • Gastroenterologische Gemeinschaftspraxis Dres. Lütke/Weismüller

    Koblenz, 56068

  • Gemeinschaftspraxis Dres. Dietel/Klugmann

    Leipzig, 4105

  • Klinikum Leverkusen Medizinische Klinik 2

    Leverkusen, 51375

  • Gemeinschaftspraxis Dres. Kocjan / Muser

    Lüdenscheid, 58507

  • Universitätsklinikum Charité

    Magdeburg, 39114

  • Gemeinschaftspraxis

    Mainz, 55116

  • Gemeinschaftspraxis Dres. Bokemeyer/Roggel/Kamp

    Minden, 32423

  • Praxisklinik Dr. Eimiller/Prof. Kellner

    München, 80335

  • Klinkum rechts der Isar der TUM

    München, 81675

  • Gemeinschaftspraxis Dres. Kardalinos/Petry

    Stuhr / Brinkum, 28816

Other trials in Germany

Czechia10 sites

  • Internal department Hospital Tábor

    Jaroše, 390 03

  • Internal department, Hospital Jičín

    Jičín, 506 43

  • Internal department Hospital Chomutov

    Kochova, 430 12

  • Hospital Mladá Boleslav - Internal Department

    Mladá Boleslav, 293 50

  • Gastroenterologie MUDr.V.Abrahámová

    Poděbrady, 290 01

  • Internal department, Hospital of Merciful sisters

    Prague, 101 00

  • Gastroenterological Centre, University Hospital of Charles University

    Prague, 120 00

  • EGK s.r.o, Gastroenterology

    Prague, 130 00

  • Internal department University Hospital Na Bulovce

    Prague, 180 00

  • Internal department Hospital

    Příbram, 261 95

Other trials in Czechia

Denmark8 sites

  • Amager Hospital Medicinsk Center

    Copenhagen S, 2300

  • Helsingor Sygehus

    Elsinore, 3000

  • Amtsygehuset i Gentofte

    Hellerup, 2900

  • Sygehus Vendsyssel

    Hjørring, 9800

  • Naestved Sygehys

    Næstved, 4700

  • Sonderborg Sygehus

    Sønderborg, 6400

  • Vejle Sygehus

    Vejle, 7100

  • Viborg Sygehus

    Viborg, 8800

Other trials in Denmark

Belgium7 sites

  • UMC Sint-Pieter

    Brussels, B-1000

  • Hôpital Erasme Unité de Recherche, Clinique Gastro-entérologie

    Brussels, B-1070

  • UZ Gent

    Ghent, B-9000

  • UZ Gasthuisberg

    Leuven, B-3000

  • CHR de la Citadelle

    Liège, B-4000

  • Heilig Hart Ziekenhuis

    Roeselaere, B-8800

  • AZ St. Augustinus

    Wilrijk, B-2610

Other trials in Belgium

Sweden6 sites

  • Centralsjukhuseet Kristianstad Medicinkliniken

    Kristianstad, 291 85

  • Ljungby Lasarett

    Ljungby

  • Endoskopienheten Lakarhuset Hoterget

    Stockholm, 111 57

  • Södersjukhuset SöS Medicinkliniken

    Stockholm, 118 83

  • Karolinska Universitetssjukhuset

    Stockholm, 171 76

  • Täby Närsjukhus

    Täby, 183 36

Other trials in Sweden

Netherlands5 sites

  • Academisch Medisch Centrum

    Amsterdam, 1100 DD

  • Medisch Spectrum Twente

    Enschede, 7511 JX

  • Ziekenhuisgroep Twente, loc. streekziekenhuis Midden-Twente

    Hengelo, 7555 DL

  • Isala klinieken

    JW Zwolle, 8011

  • Ikazia ziekenhuis

    Rotterdam, 3083 AN

Other trials in Netherlands

Norway2 sites

  • Ullevål Universitetssykehus HF

    Oslo, 0407

  • Aker universitetssykehus HF

    Oslo, 0514

Other trials in Norway

Finland1 site

  • North Karelia Central Hospital

    Joensuu, 80210

Other trials in Finland

About this study

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

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.
Being tested
Pentasa
Keywords
Ulcerative Colitis for Maintenance of Remission
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PentasaDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionMay 2007
  4. Study completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
362 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00209300
Sponsor's protocol ID
FE999907 CS003
Other IDs
2004-004565-15, 2004
Status last verified
May 2011
First submitted
13 Sep 2005
Last updated
19 May 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pentasa in people with Ulcerative Colitis, run by Ferring Pharmaceuticals at 69 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in Germany, Czechia, Denmark, Belgium, Sweden and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00209300.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.

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