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

Phase 3

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT00548574
• Lead Sponsor: Shire

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12-04
• Primary Completion: 2004-10-20
• Study Completion: 2004-10-20
• Study First Submitted: 2007-10-23
• Study First Submitted QC: 2007-10-23
• Study First Posted: 2007-10-24
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)	8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Imelda General Hospital Dept of Gastroenterology; 🇧🇪 Bonheiden, Belgium