Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis

Study Overview
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Brief Summary
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The primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day once daily versus placebo

Official Title
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A Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine
* Drug: Mesalazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly diagnosed or relapsing mild to moderate UC (score of 4-10 (inclusive) on the UC-DAI scale, with a sigmoidoscopy score of => 1 and a PGA <=2) with compatible histology females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy test at screening and were on adequate contraception Exclusion Criteria: subjects with relapsing UC who were in relapse for > 6 weeks prior to baseline subjects who relapsed on maintenace therapy with doses of mesalazine => 2g/day subjects who had unsuccessfully treated their current relapse with steroids or a mesalazine dose of > 2g/day subjects with Crohn's disease, proctitis, bleeding disorders, active peptic ulcer disease, previous colonic surgery, or those at an immediate risk of toxic megacolon or a stool culture positive for enteric pathogens subjects who had used systemic or rectal steroids within the last 4 weeks, immunosuppressants wihtin the last 6 weeks or anti-inflammatory drugs on a repeat basis within 7 days prior to the baseline visit subjects with hypersensitivity to salicylates and subjects with moderate/severe renal impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine|nan|
|Drug: Mesalazine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects in remission (UC-DAI score <=1, with scores of 0 for rectal bleeding and stool frequency and a sigmoidoscopy score reduction of 1 point or more from baseline) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score |  | 8 weeks | 
| Change from baseine in UC-DAI score, symptoms, sigmoidscopy score, and PGA |  | 8 weeks | 
| Clinical remission defined as subjects who scored 0 for both the total stool frequency and the total rectal bleeding score |  | 8 weeks | 
| Treatment failure defined as unchanged, worsened missing or imcomplete UC-DAI score |  | 8 weeks |