Trial Details
COMPLETEDBasic Information
| Clinical ID | c1571 |
|---|---|
| Identifier | NCT00548574 |
| Trial Title | Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis |
| Trial URL | Visit Original Page |
Study Information
| Study Results | NO |
|---|---|
| Conditions | Ulcerative Colitis |
| Interventions | DRUG: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine|DRUG: Mesalazine |
Participant Information
| Sponsor | Shire |
|---|---|
| City | Bonheiden |
| Country/Region | Belgium |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | ADULT, OLDER_ADULT |
Study Design
| Study Type | INTERVENTIONAL |
|---|---|
| Phase | PHASE3 |
Time Information
| Start Date | 2003-12-04 |
|---|---|
| Primary Completion Date | 2004-10-20 |
| Completion Date | 2004-10-20 |