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

Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period. After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.

Detailed description

Each patient will receive one of the following regimens in the morning after breakfast: 1. One budesonide MMX® 6 mg tablet plus three placebo Entocort enteric-coated (EC®) overencapsulated capsules, or 2. One budesonide MMX® 9 mg tablet plus three placebo Entocort EC® overencapsulated capsules, or 3. Three placebo Entocort EC® overencapsulated capsules plus one placebo budesonide MMX® tablet, or 4. Three Entocort EC® 3 mg overencapsulated capsules plus one placebo budesonide MMX® tablet, daily for eight weeks. Hence, each patient is to take four tablets/capsules per day of active or placebo study medication as per the randomization schedule. Placebo tablets of Budesonide MMX® and placebo overencapsulated capsules of Entocort EC® will be used to maintain the study blind using a double-dummy technique. During the study, five visits to the clinical center are scheduled: one at Screening and three in the double-blind treatment period (Day 1, Day 14, Day 28 and Day 56). A safety follow-up visit will take place about 2 weeks after the final study visit. If a patient is withdrawn from the study before Day 56, they will be asked to attend the study center as soon as possible thereafter so that the Final visit assessments can be conducted.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
PROCEDURE	Blood sampling, endoscopy	Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores
DRUG	Budesonide MMX® 6 mg	6 mg/day, 6 mg tablets
DRUG	Budesonide MMX® 9 mg	9 mg/day, 9 mg tablets
DRUG	Entocort EC® 3 mg	9 mg/day, 3 mg tablets
DRUG	Placebo	Placebo

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-02-01
• Completion: 2010-04-01
• First posted: 2008-05-16
• Last updated: 2019-12-10
• Results posted: 2014-08-01

Locations

71 sites across 15 countries: Australia, Belgium, Estonia, France, Israel, Italy, Latvia, Lithuania, Poland, Romania, Russia, Slovakia, Sweden, Ukraine, United Kingdom