Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM

Ferring BV0 sites360 target enrollmentStarted: February 24, 2005Last updated: April 24, 2012

Study Overview

No summary available.

•INCLUSION CRITERIA:
•1.Patients have an established diagnosis of ulcerative colitis and are in clinical remission with an UC-DAI < 2 at enrolment,
•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 gram per day,
•5.18 years or older,
•6.Signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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,
•3.Patients who used mesalazine > 2.5 grams orally in the previous month,
•4.Patients who use 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 disorder, that would interfere with their participation in the study,
•10.Women who are pregnant or nursing (non-menopausal women who are sexually active and use not 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.

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