Mild to Moderate Ulcerative Colitis Clinical Trial
Official title:
Multi Center Ulcerative Colitis Pediatric Pentasa Intervention Trial (MUPPIT). A Randomized, Single-blinded, Controlled, Parallel, Induction Therapy With Once vs. Twice Daily Dosing of Pentasa in Pediatric UC.
The purpose of this study is to evaluate effectiveness of once daily dosing of Pentasa compared with twice daily in children with mild to moderate active ulcerative colitis.
Several randomized controlled trials (RCTs) have affirmed the efficacy of 5-aminosalicylic
acid (5-ASA) and sulfasalazine in the acute treatment of mild to moderate exacerbations, as
well as in the maintenance of clinical remission. Initially, common practice was to
prescribe 5-ASA in three divided doses. Slow release once daily mesalamine with Multi Matrix
System (MMX) technology was shown to be effective in induction and maintenance of remission
of adult ulcerative colitis (UC). Since transit time of the colon is much slower than the
small-bowel, and since the active ingredient should act locally on the colon, less frequent
dosing of the regular formulation may also provide sufficient colonic coverage. Indeed, two
recent studies among adults with UC suggest that once daily dosing of mesalamine (Pentasa®
and Salofalk®) may be as or more effective than twice daily dosing.
To date, most RCTs have been conducted among adult patients and efficacy in children has
been extrapolated from these data. However, childhood inflammatory bowel disease (IBD) may
not be similar to adult onset disease. The prevalence of extensive colitis proximal to the
splenic flexure is doubled in pediatric-onset UC compared to adults and extensive disease is
consistently associated with more severe phenotype. On the other hand, studies in children
with IBD often show better response to therapy than in adults. Therefore, American and
European regulating agencies encourage pediatric studies be conducted for all approved drug
products. It has been found that less than 50% of children with IBD are adherent with
treatment, a figure associated with the understanding of the disease which is generally
lower than in adults. Therefore, the advantage of once daily dosing of 5-ASA over
twice-daily may be greater in children compares with adults.
The investigators hypothesize that once daily dosing of mesalamine is superior in
effectiveness to twice daily dosing to induce remission in pediatric mild-moderate UC. We
base this hypothesis on data previously found in adults and due to the expected higher
adherence rate.
This study will compare two groups receiving an identical dose of the same non experimental
medication, with the only difference being in the number of doses of the medication!
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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