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
Phase 3
Completed
- Conditions
- Colitis, Ulcerative
- Registration Number
- NCT00503243
- Lead Sponsor
- Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 8 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States