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

Shire38 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Colitis, Ulcerative

Interventions

SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Imelda General Hospital

Bonheiden, Belgium

Outcomes

Primary Outcomes

% of subjects in remission (UC-DAI score)

Time frame: Week 8

Secondary Outcomes

Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology

Time frame: 8 weeks

Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA

Time frame: 8 weeks

Safety and tolerability

Time frame: 8 weeks

Data from ClinicalTrials.gov

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