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Sponsored by: |
Ferring Pharmaceuticals |
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Information provided by: | Ferring Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00737789 |
The purpose of this study is to demonstrate that mesalazine po 4g per day once daily (QD.) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID.) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks, in terms of remission evaluated with the UC-DAI score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) will receive an enema containing 1g of mesalazine at bedtime during the initial 4 weeks.
Condition | Intervention | Phase |
---|---|---|
Ulcerative Colitis |
Drug: Mesalazine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis. |
Estimated Enrollment: | 398 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
T: Experimental
Mesalazine Test regimen: Pentasa (mesalazine) 2g Sachet prolonged release granules (95%) 4g/day po once daily (QD.) for 8 weeks. Plus an enema containing 1g of mesalazine at bedtime during the initial 4 weeks. Follow-up period: 4 weeks Pentasa (mesalazine) 2g Sachet prolonged release granules (95%) 2g/day po once daily (1 sachet/day) |
Drug: Mesalazine
T, Test QD, 01 T, Test QD, 02
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C: Active Comparator
Mesalazine Reference regimen: Pentasa (mesalazine) 2g Sachet prolonged release granules (95%) 4g (2g x 2)/day po (BID.) for 8 weeks. Plus an enema containing 1g of mesalazine at bedtime during the initial 4 weeks. Follow-up period: 4 weeks Pentasa (mesalazine) 2g Sachet prolonged release granules (95%) 2g/day po once daily (1 sachet/day). |
Drug: Mesalazine
C, Comparator BID, 01 C, Comparator BID, 02
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A key element in therapeutic response in UC is treatment compliance. In daily practice, compliance of UC patients with 5-ASA treatment appears mediocre, particularly in maintenance therapy. Poor or non-existent compliance affects not only treatment response but also disease progression.
An inverse relationship has been found between the number of daily doses prescribed and treatment compliance. Thus, reduction to a single daily dose of mesalazine is a major factor likely to significantly increase treatment compliance
Reducing the dosing rate to a single daily dose for 8 weeks constitutes a simple method of improving treatment compliance but it is necessary to demonstrate at least equivalent efficacy compared to the twice daily dosing which is the reference regimen. This study is designed to show that mesalazine 4 g. once daily is at least as effective as mesalazine 4 g. in two divided doses per day in patients with mild to moderate ulcerative colitis after 8 weeks of treatment with a better compliance. To improve remission, both groups will receive an enema during the first 4 weeks, as usually done in current practice.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be included if they comply with the following inclusion criteria determined at baseline, prior to first drug administration:
Exclusion Criteria:
The patients will not be included in the study if one of the following exclusion criteria is fulfilled at baseline, prior to first drug administration:
Contact: Sylvie Forestier, MD | +33149088516 |
France, Gentilly | |
Ferring SAS | |
7 rue Jean-Baptiste Clement, Gentilly, France, 94250 |
Principal Investigator: | Bernard Flourie, Pr | Centre Hospitalier Lyon Sud |
Responsible Party: | Ferring SAS ( Dr. Sylvie Forestier ) |
Study ID Numbers: | Pentasa FE 999907 CS06, EudractCT No 2008-000045-59 |
Study First Received: | August 19, 2008 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00737789 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Digestive System Diseases Mesalamine Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |
Anti-Inflammatory Agents Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Pharmacologic Actions |