Overview

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

Status:
Completed
Trial end date:
2004-10-20
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shire
Treatments:
Mesalamine
Criteria
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