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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00151892 | Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis | PHASE3 | COMPLETED | 829 | — | — | Apr 8, 2005 | Sep 7, 2009 | Jun 14, 2021 | 142 | United States, Argentina +26 |
Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal \[intact vascular pattern; no friability or granulation\], 1 = mild \[erythema; decreased vascular pattern; minimal granularity\], 2 = moderate \[marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations\], 3 = severe \[ulceration; spontaneous bleeding\].
| Arm | Type | Description |
|---|---|---|
| SPD476 | EXPERIMENTAL | Mesalazine |
| Asacol | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SPD476 | DRUG | 2.4 g/day Once Daily (QD) |
| Asacol | DRUG | 1.6g/day administered 800 mg Twice Daily (BID) |
Inclusion Criteria: * previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for =\> 30 days * female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contr...