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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Trial Officials
Clinical Development Support
Study Director
Ferring Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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