NCT00548574

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine
DRUG	Mesalazine

Timeline

• Start date: 2003-12-04
• Primary completion: 2004-10-20
• Completion: 2004-10-20
• First posted: 2007-10-24
• Last updated: 2021-06-11

Locations

1 site across 1 country: Belgium