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

Shire1 site in 1 country343 target enrollmentDecember 4, 2003

ConditionsUlcerative Colitis

DrugsSPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine Mesalazine

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Ulcerative Colitis
Sponsor: Shire
Enrollment: 343
Locations: 1
Primary Endpoint: 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)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 4, 2003

End Date

October 20, 2004

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 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

Outcomes

Primary Outcomes

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)

Time Frame: 8 weeks

Secondary Outcomes

Treatment failure defined as unchanged, worsened missing or imcomplete UC-DAI score(8 weeks)
Clinical remission defined as subjects who scored 0 for both the total stool frequency and the total rectal bleeding score(8 weeks)
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)