Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Delayed and extended release mesalazine

Primary Measures

• 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 Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shire Pharmaceutical Development

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00503243

Study ID Number: SPD476-301

ClinicalTrials.gov Identifier: NCT00503243

Health Authority: United States: Food and Drug Administration

FDA-approved label, US only

FDA Recall information

FDA Medical Product Safety Alerts

Synopsis of study results