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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00679380 | (CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis | PHASE3 | COMPLETED | 514 | — | — | Jun 1, 2008 | Apr 1, 2010 | Dec 10, 2019 | 71 | Australia, Belgium +13 |
Clinical and endoscopic remission defined as an Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.
| Arm | Type | Description |
|---|---|---|
| 1: budesonide-MMX® 6 mg | EXPERIMENTAL | One budesonide-MMX® 6 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast. |
| 2: budesonide-MMX® 9 mg | EXPERIMENTAL | One budesonide-MMX® 9 mg plus three placebo Entocort EC® overencapsulated capsules daily in the morning after breakfast. |
| 3: Entocort EC® 3 mg | ACTIVE_COMPARATOR | Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet daily in the morning after breakfast. |
| 4: Placebo | PLACEBO_COMPARATOR | Three placebo Entocort EC® overencapsulated capsules plus one placebo Budesonide MMX® tablet daily in the morning after breakfast. |
| Name | Type | Description |
|---|---|---|
| Blood sampling, endoscopy | PROCEDURE | Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores |
| Budesonide MMX® 6 mg | DRUG | 6 mg/day, 6 mg tablets |
| Budesonide MMX® 9 mg | DRUG | 9 mg/day, 9 mg tablets |
| Entocort EC® 3 mg | DRUG | 9 mg/day, 3 mg tablets |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Patients fulfilling the following criteria at the screening visit are eligible for participation in the study: * Male and female patients, 18-75 years old, suffering from ulcerative colitis for at least 6 months. * Diagnosis of ulcerative colitis in active phase, of mild ...