Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476
Phase 2
Completed
- Conditions
- Colitis, Ulcerative
- Registration Number
- NCT00545389
- Lead Sponsor
- Shire
- Brief Summary
Evaluate the percentage of subjects in remission at the end of an 8-week treatment period for three dose groups (SPD476 1.2 g/day, 2.4 g/day or 4.8 g/day, administered once daily).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
- male & female subjects greater than or equal to 18 years of age with newly diagnosed or relapsing mild to moderate ulcerative colitis
- general medical assessment satisfactory and no clinically significant and relevant abnormalities
Exclusion Criteria
- severe ulcerative colitis
- subject in relapse for > 6 weeks
- use of systemic or rectal steroids within last 4 weeks prior to baseline
- subjects with proctitis, previous colonic surgery, Crohn's disease, bleeding disorders, active ulcer disease
- subjects hypersensitive to salicylates/aspirin
- subjects with moderate or severe renal impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method % of subjects in remission (UC-DAI score) Week 8
- Secondary Outcome Measures
Name Time Method Change in UC-DAI score by dose and by diagnosis, change in symptoms, change in sigmoidoscopic (mucosal) appearance, change in histology 8 weeks Plasma levels & mucosal levels of 5-ASA and Ac-5-ASA 8 weeks Safety and tolerability 8 weeks
Trial Locations
- Locations (1)
Imelda General Hospital
🇧🇪Bonheiden, Belgium