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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00486031 | Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study | PHASE3 | COMPLETED | 443 | — | — | Oct 1, 2006 | Dec 1, 2008 | Aug 15, 2019 | 95 | United States |
| NCT00408174 | Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis | PHASE3 | COMPLETED | 400 | — | — | May 1, 2006 | Nov 1, 2007 | Nov 25, 2019 | 88 | United States |
Incidence of treatment emergent adverse events
| Arm | Type | Description |
|---|---|---|
| balsalazide disodium tablets,3.3 g BID, | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Balsalazide Disodium | DRUG | - |
Inclusion Criteria: * Subject has a documented history of UC and is either in remission or currently presents with mildly to moderately active UC symptoms as determined by the investigator upon subject interview of UC symptoms, (e.g., urgency, bowel frequency, and rectal bleeding). Additionally, th...