CompletedNCT00503243Updated Jun 11, 2021

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 3 interventional study of Delayed and extended release mesalazine in Colitis, Ulcerative, sponsored by Shire. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-11.

Sponsored by Shire · Phase 3, Interventional, and Treatment

From the registry’s dates

Registered 3 years 9 months after the study started (first participant enrolled Sep 2003, registered Jul 2007).

Phase: Phase 3
Study type: Interventional
Enrollment: 280
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Colitis, Ulcerative

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In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 280 is above the median of 60 across 771 interventional studies indexed under Colitis.

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Lead sponsor

Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double
Enrollment: 280 participants (actual)

Interventions

DrugDelayed and extended release mesalazine

What researchers measure

Primary outcomes

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
Time frame: 8 weeks

Secondary outcomes

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

Study locations

1 site

University of Pennsylvania
Philadelphia, Pennsylvania, United States

References and documents

Publications

Lichtenstein GR, Kamm MA, Boddu P, Gubergrits N, Lyne A, Butler T, Lees K, Joseph RE, Sandborn WJ. Effect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis. Clin Gastroenterol Hepatol. 2007 Jan;5(1):95-102. doi: 10.1016/j.cgh.2006.10.025. PubMed 17234558 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00503243
Lead sponsor: Shire
Responsible party: Sponsor
First posted: Jul 18, 2007
Start date: Sep 30, 2003
Primary completion: Jan 17, 2005
Completion: Jan 17, 2005
Last update: Jun 11, 2021

Study contacts

Study Director

study director · Takeda

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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