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(CB-01-02/01)Randomized Placebo Controlled Trial of Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg in Patients With Ulcerative Colitis

2014-08-27 03:30:33 | BioPortfolio

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.

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 If a patient is withdrawn from the study before Day 56, they will be asked to attend the study center as soon as possible thereafter so that the Final visit assessments can be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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Ulcerative Colitis

Intervention

Blood sampling, endoscopy, budesonide-MMX® 6 mg, budesonide-MMX® 9 mg, Placebo, Asacol® 400 mg

Location

Santarus Clinical Investigational Site 5051
Huntsville
Alabama
United States
35801

Status

Active, not recruiting

Source

Santarus

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:30:33-0400

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