At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.
In Brief
A Phase 3 clinical trial evaluating Blood sampling, endoscopy, budesonide-MMX® 6 mg, and 3 other interventions for Ulcerative Colitis. Completed, enrolled 510 participants across 105 sites in 4 countries.
Detailed Summary
The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.
Study Details
Timeline
Interventions
Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
6 mg/day, 6 mg tablets
9 mg/day, 9 mg tablets
Placebo
2400 mg/day, 400 mg tablets