Status:
COMPLETED
Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT00209300
Start Date
May 1 2005
End Date
June 1 2007
Last Update
May 19 2011
Active Locations (69)
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1
UMC Sint-Pieter
Brussels, Belgium, B-1000
2
Hôpital Erasme Unité de Recherche, Clinique Gastro-entérologie
Brussels, Belgium, B-1070
3
UZ Gent
Ghent, Belgium, B-9000
4
UZ Gasthuisberg
Leuven, Belgium, B-3000