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

Shire

Status and phase

Completed

Phase 2

Conditions

Colitis, Ulcerative

Treatments

Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00545389

SPD476-202

Details and patient eligibility

About

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).

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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