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

Shire

Status and phase

Completed

Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine

Drug: Mesalazine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00548574

SPD476-302

Details and patient eligibility

About

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

Enrollment

343 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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