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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00744016 | Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis | PHASE3 | COMPLETED | 305 | — | — | Dec 1, 2004 | Oct 1, 2007 | Nov 27, 2019 | 1 | United States |
| NCT00767728 | Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis | PHASE3 | COMPLETED | 256 | — | — | Dec 1, 2004 | Oct 1, 2007 | Nov 27, 2019 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 2 | PLACEBO_COMPARATOR | Placebo |
| 1 | ACTIVE_COMPARATOR | Granulated mesalamine |
| Name | Type | Description |
|---|---|---|
| Granulated mesalamine | DRUG | 0.375 g of mesalamine granules were encapsulated in a hard gelatin shell. 1.5 g of eMG (4 capsules) were administered orally QD, in the morning |
| Placebo | DRUG | Matching placebo capsules (4 capsules) were administered orally QD, in the morning |
Inclusion Criteria: * Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month. * Greater than 18 years of age. Exclusion Criteria: * Allergy/intolerance to aspirin, mesalamine or other salicylates. * Prior bowel surgery other than appendectomy. * Pregnancy, at risk of preg...