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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Each patient will receive one of the following regimens in the morning after breakfast: 1. one budesonide-MMX™ 6 mg tablet plus two placebo Asacol® over encapsulated tablets, or 2. one budesonide-MMX™ 9 mg tablet plus two placebo Asacol® over encapsulated tablets, or 3. two placebo Asacol® over encapsulated tablets plus one placebo budesonide tablet, or 4. two Asacol® 400 mg over encapsulated tablets plus one placebo budesonide tablet, daily for 8 weeks. Each patient will also receive on each day after the midday meal and after the evening meal either: * two Asacol® 400 mg over-encapsulated tablets (Group 4), or * the equivalent placebo Asacol® over-encapsulated tablets, (Groups 1, 2 and 3) Hence, each patient is to take seven tablets per day of active or placebo study medication as per the randomization schedule. Placebo tablets of budesonide-MMX™ and placebo over-encapsulated tablets of Asacol® 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 If a patient is withdrawn from the study before Day 56, they will be asked to attend the study center as soon as possible thereafter so that the Final visit assessments can be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	Placebo	Placebo
DRUG	Asacol® 400 mg	2400 mg/day, 400 mg tablets

Timeline

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

Locations

105 sites across 4 countries: United States, Canada, India, Mexico