Trials / Completed
CompletedNCT00545389
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine |
Timeline
- Start date
- 2003-02-10
- Primary completion
- 2004-10-20
- Completion
- 2004-10-20
- First posted
- 2007-10-17
- Last updated
- 2021-06-11
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT00545389. Inclusion in this directory is not an endorsement.