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

A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503243

Enrollment

280

Registered

2007-07-18

Start date

2003-09-30

Completion date

2005-01-17

Last updated

2021-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Ulcerative

Brief summary

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.

Interventions

DRUGDelayed and extended release mesalazine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of subjects in remission (Ulcerative Colitis Disease Activity Index score of <= 1, with scores of 0 for rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline	8 weeks

Secondary

Measure	Time frame
Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score	8 weeks
Change in the UC-DAI score	8 weeks
Change in symptoms (rectal bleeding and stool frequency)	2, 4 and 8 weeks
Change in sigmoidoscopic (mucosal) appearance	8 weeks
Time to withdrawal from the start of study medication	Throughout the study period of 8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026