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Search / Trial NCT00209300

Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

Launched by FERRING PHARMACEUTICALS · Sep 19, 2005

Trial Information

Current as of July 21, 2025

Completed

Keywords

Ulcerative Colitis For Maintenance Of Remission

ClinConnect Summary

No description provided

Gender

ALL

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.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a global biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapies that address unmet medical needs in various therapeutic areas, including reproductive health, urology, and gastrointestinal disorders. With a strong commitment to advancing healthcare through scientific excellence and patient-centered solutions, Ferring leverages its extensive expertise in hormone-related treatments and personalized medicine. The company actively engages in clinical research to develop safe and effective therapies, striving to improve the quality of life for patients worldwide while maintaining a focus on ethical practices and collaboration in the healthcare community.

Locations

Vejle, , Denmark

Hellerup, , Denmark

Amsterdam, , Netherlands

Bochum, , Germany

Leuven, , Belgium

Bruxelles, , Belgium

Bruxelles, , Belgium

Gent, , Belgium

Liège, , Belgium

Roeselaere, , Belgium

Wilrijk, , Belgium

Jaroše, , Czech Republic

Jičín, , Czech Republic

Kochova, , Czech Republic

Mladá Boleslav, , Czech Republic

Poděbrady, , Czech Republic

Prague 2, , Czech Republic

Prague 8, , Czech Republic

Praha 3, , Czech Republic

Praha, , Czech Republic

Příbram, , Czech Republic

Copenhagen S, , Denmark

Helsingor, , Denmark

Hjørring, , Denmark

Naestved, , Denmark

Soenderborg, , Denmark

Viborg, , Denmark

Joensuu, , Finland

Augsburg, , Germany

Beeskow, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Bonn, , Germany

Dachau, , Germany

Dinkelsbühl, , Germany

Dortmund, , Germany

Dresden, , Germany

Erlangen, , Germany

Frankfurt A.M., , Germany

Görlitz, , Germany

Hamburg, , Germany

Hannover, , Germany

Hof, , Germany

Homberg/Efze, , Germany

Koblenz, , Germany

Köln, , Germany

Leipzig, , Germany

Leverkusen, , Germany

Luedenscheid, , Germany

Magdeburg, , Germany

Mainz, , Germany

Minden, , Germany

München, , Germany

München, , Germany

Stuhr / Brinkum, , Germany

Enschede, , Netherlands

Hengelo, , Netherlands

Jw Zwolle, , Netherlands

Rotterdam, , Netherlands

Oslo, , Norway

Oslo, , Norway

Kristianstad, , Sweden

Ljungby, , Sweden

Stockholm, , Sweden

Stockholm, , Sweden

Stockholm, , Sweden

Täby, , Sweden

Patients applied

0 patients applied

Trial Officials

Clinical Development Support

Study Director

Ferring Pharmaceuticals

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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