Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476

• Status: Completed
• Trial end date: 2004-10-20
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• male & female subjects greater than or equal to 18 years of age with newly diagnosed or relapsing mild to moderate ulcerative colitis

• general medical assessment satisfactory and no clinically significant and relevant abnormalities

Exclusion Criteria:

• severe ulcerative colitis

• subject in relapse for > 6 weeks

• use of systemic or rectal steroids within last 4 weeks prior to baseline

• subjects with proctitis, previous colonic surgery, Crohn's disease, bleeding disorders, active ulcer disease

• subjects hypersensitive to salicylates/aspirin

• subjects with moderate or severe renal impairment