(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Blood sampling, endoscopy; Budesonide MMX® 6 mg; Budesonide MMX® 9 mg; Entocort EC® 3 mg; Placebo
Intervention type(s): Procedure; Drug; Drug; Drug; Drug
Intervention description(s): 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; 9 mg/day, 3 mg tablets; Placebo
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative colitis