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

Ulcerative Colitis Clinical Trial

Official title:

A Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the 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 Mild to Moderate Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548574
• Other study ID #: SPD476-302
• Status: Completed
• Phase: Phase 3
• Start date: December 4, 2003
• Est. completion date: October 20, 2004

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: October 20, 2004
• Est. primary completion date: October 20, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

• Mesalazine

Locations

Country	Name	City	State
Belgium	Imelda General Hospital Dept of Gastroenterology	Bonheiden

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Kamm MA, Sandborn WJ, Gassull M, Schreiber S, Jackowski L, Butler T, Lyne A, Stephenson D, Palmen M, Joseph RE. Once-daily, high-concentration MMX mesalamine in active ulcerative colitis. Gastroenterology. 2007 Jan;132(1):66-75; quiz 432-3. Epub 2006 Oct — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects in remission (UC-DAI score <=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 from baseine in UC-DAI score, symptoms, sigmoidscopy score, and PGA		8 weeks
Secondary	Clinical remission defined as subjects who scored 0 for both the total stool frequency and the total rectal bleeding score		8 weeks
Secondary	Treatment failure defined as unchanged, worsened missing or imcomplete UC-DAI score		8 weeks

External Links

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