The purpose of this study was to demonstrate that mesalazine 4g orally 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 Ulcerative Colitis Disease Activity Index (UC-DAI) score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema containing 1g of mesalazine at bedtime during the initial 4 weeks. Participants in remission at week 8 received an additional 4 weeks of maintenance therapy with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8 completed the study at week 8.
A key element in therapeutic response in UC is treatment compliance. In daily practice, compliance of UC patients with 5-Amino Salicylic Acid (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 was designed to show that mesalazine 4g once daily is at least as effective as mesalazine 4g 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 received an enema during the first 4 weeks, as usually done in current practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
206
Mesalazine 2g Sachet prolonged release granules, administered orally.
1g mesalazine liquid enema, administered topically once a day in the evening.
O.L.Vrouwziekenhuis Campus Aalst
Aalst, Belgium
C.H.U. Saint-Pierre
Brussels, Belgium
Saint Luc University Hospital
Brussels, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
U.Z. Antwerpen
Edegem, Belgium
University Hospital Gasthuisberg
Primary efficacy criterion: remission after 8 weeks of treatment, defined on the basis of the UC-DAI score less than or equal to 1
Time frame: 12 weeks
Compliance
Time frame: Week 8
Clinical remission
Time frame: At week 4, week 8 and week 12
Treatment failure is defined as need of other treatment (ie steroids, immunosuppressive or immunomodulating drugs) than those allowed by the protocol, as judged by investigator. Treatment failure will be counted as non-remission.
Time frame: At week 4 and week 8
Clinical variables (stool frequency and bloody stools)
Time frame: At week 4, 8 and 12 separately
Time to remission according to patient's diary (normal stool frequency and cessation of bleeding)
Time frame: At week 4 and week 8
Time to cessation of bleeding
Time frame: At week 4, week 8 and week 12
Improvement - based on UC-DAI score
Time frame: At week 4 and 8
Endoscopic assessment
Time frame: At week 0 and week 8
Safety
Time frame: At week 0, week 4, week 8 and week 12
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Leuven, Belgium
Clinique Esquirol-St Hilaire
Agen, France
Investigational site
Albi, France
Investigational site
Amiens, France
Centre Hospitalier Avignon
Avignon, France
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