A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

Shire1 site in 1 country280 target enrollmentSeptember 30, 2003

ConditionsColitis, Ulcerative

DrugsDelayed and extended release mesalazine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Colitis, Ulcerative
Sponsor: Shire
Enrollment: 280
Locations: 1
Primary Endpoint: Percentage of subjects in remission (Ulcerative Colitis Disease Activity Index score of <= 1, with scores of 0 for rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 30, 2003

End Date

January 17, 2005

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Percentage of subjects in remission (Ulcerative Colitis Disease Activity Index score of <= 1, with scores of 0 for rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline

Time Frame: 8 weeks

Secondary Outcomes

Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score(8 weeks)
Change in symptoms (rectal bleeding and stool frequency)(2, 4 and 8 weeks)
Change in sigmoidoscopic (mucosal) appearance(8 weeks)
Change in the UC-DAI score(8 weeks)
Time to withdrawal from the start of study medication(Throughout the study period of 8 weeks)