Trials / Completed
CompletedNCT00503243
Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis
A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 280 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study was to investigate the safety and efficacy of SPD476 2.4 g/day given twice daily (\[BID\] ie 1.2 g/day BID) and SPD476 4.8g/day given QD compared to placebo in subjects with acute, mild to moderate ulcerative colitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Delayed and extended release mesalazine |
Timeline
- Start date
- 2003-09-30
- Primary completion
- 2005-01-17
- Completion
- 2005-01-17
- First posted
- 2007-07-18
- Last updated
- 2021-06-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00503243. Inclusion in this directory is not an endorsement.