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

Study Timeline

• Study Start: 2003-02-10
• Primary Completion: 2004-10-20
• Study Completion: 2004-10-20
• Study First Submitted: 2007-10-16
• Study First Submitted QC: 2007-10-16
• Study First Posted: 2007-10-17
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-11

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