Ulcerative Colitis
Conditions
Brief 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
Interventions
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Clinical improvement as defined by a drop of => 3 points from baseline in the overall UC-DAI score | 8 weeks |
| Change from baseine in UC-DAI score, symptoms, sigmoidscopy score, and PGA | 8 weeks |
| Clinical remission defined as subjects who scored 0 for both the total stool frequency and the total rectal bleeding score | 8 weeks |
| Treatment failure defined as unchanged, worsened missing or imcomplete UC-DAI score | 8 weeks |
Countries
Belgium
Outcome results
None listed