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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00679432 | (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis | PHASE3 | COMPLETED | 510 | — | — | Jun 1, 2008 | Jun 1, 2010 | Dec 10, 2019 | 105 | United States, Canada +2 |
Clinical and endoscopic remission defined as a 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 two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. |
| 2: budesonide-MMX® 9 mg | EXPERIMENTAL | One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. |
| 3: Placebo | PLACEBO_COMPARATOR | Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. |
| 4: Asacol® 400 mg | ACTIVE_COMPARATOR | Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. |
| 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 |
| Placebo | DRUG | Placebo |
| Asacol® 400 mg | DRUG | 2400 mg/day, 400 mg tablets |
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 ...