Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

Shire

Status and phase

Completed

Phase 3

Conditions

Colitis, Ulcerative

Treatments

Drug: Delayed and extended release mesalazine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00503243

SPD476-301

2004-000733-12 (EudraCT Number)

Details and patient eligibility

About

The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily ([BID] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative colitis.

Enrollment

280 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

newly diagnosed or diagnosis of relapsing (relapsed <= 6 weeks to baseline) mild to moderate ulcerative colitis
women not of childbearing potential or WOCP who agreed to use an effective contraceptive method

Exclusion criteria

severe ulcerative colitis or relapsed for > 6 weeks prior to baseline
subjects who had relapsed on maintenance therapy with doses of mesalazine > 2.0 g/day
subjects with Crohn's disease, proctitis, bleeding disorders or active peptic ulcer disease
subjects with asthma if they were known to be mesalazine-sensitive
subjects who were at immediate or significant risk of toxic megacolon
subjects who had previous resective colonic surgery
subjects who had moderate or severe renal impairment