Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-01-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Colitis, Ulcerative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Delayed and extended release mesalazine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No