Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily 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

343 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-04

Study Completion Date

2004-10-20

Brief Summary

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The primary objective of the study was to compare the percentage of subjects in remission after 8 weeks of treatment with SPD476, 2.4 g/day once daily vs placebo and SPD476 4.8 g/day once daily versus placebo

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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

Intervention Type DRUG

Mesalazine

Intervention Type DRUG

Other Intervention Names

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LIALDA ASACOL

Eligibility Criteria

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Inclusion Criteria

* newly diagnosed or relapsing mild to moderate UC (score of 4-10 (inclusive) on the UC-DAI scale, with a sigmoidoscopy score of =\> 1 and a PGA \<=2) with compatible histology
* females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy test at screening and were on adequate contraception

Exclusion Criteria

* subjects with relapsing UC who were in relapse for \> 6 weeks prior to baseline
* subjects who relapsed on maintenace therapy with doses of mesalazine =\> 2g/day
* subjects who had unsuccessfully treated their current relapse with steroids or a mesalazine dose of \> 2g/day
* subjects with Crohn's disease, proctitis, bleeding disorders, active peptic ulcer disease, previous colonic surgery, or those at an immediate risk of toxic megacolon or a stool culture positive for enteric pathogens
* subjects who had used systemic or rectal steroids within the last 4 weeks, immunosuppressants wihtin the last 6 weeks or anti-inflammatory drugs on a repeat basis within 7 days prior to the baseline visit
* subjects with hypersensitivity to salicylates and subjects with moderate/severe renal impairment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No