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

Colitis, Ulcerative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503243
• Other study ID #: SPD476-301
• Secondary ID: 2004-000733-12
• Status: Completed
• Phase: Phase 3
• Start date: September 30, 2003
• Est. completion date: January 17, 2005

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: January 17, 2005
• Est. primary completion date: January 17, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• Delayed and extended release mesalazine

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 He — View Citation

Outcome

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

External Links

•   FDA Recall information
•   FDA-approved label, US only