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

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

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-10

Study Completion Date

2004-10-20

Brief Summary

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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).

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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

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

Other Intervention Names

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LIALDA

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No