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

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