Trial | NCT00545389  Report issue

Title

Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476
A Phase II, Randomized, Multi-centre, Double-blind, Parallel-group, Dose-ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once Daily

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    mesalamine ...

  • Study Participants

    38
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).
Study Started
Feb 10
2003
Primary Completion
Oct 20
2004
Study Completion
Oct 20
2004
Last Update
Jun 11
2021

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

  • Other names: LIALDA

Criteria 

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
No Results Posted