Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00548574 | 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 | PHASE3 | COMPLETED | 343 | — | — | Dec 4, 2003 | Oct 20, 2004 | Jun 11, 2021 | 1 | Belgium |
| Name | Type | Description |
|---|---|---|
| SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine | DRUG | - |
| Mesalazine | DRUG | - |
Inclusion Criteria: * newly diagnosed or relapsing mild to moderate UC (score of 4-10 (inclusive) on the UC-DAI scale, with a sigmoidoscopy score of =\> 1 and a PGA \<=2) with compatible histology * females eligible if post--menopausal, surgically sterile or if they had a negative urine pregnancy t...