Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 510
Healthy volunteers: no

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 If a patient is withdrawn from the study before Day 56, they will be asked to attend the study center as soon as possible thereafter so that the Final visit assessments can be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

Arms:
arm 1: One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. arm 2: One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. arm 3: Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. arm 4: Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.

Interventions: intervention 1: Blood sampling, endoscopy intervention 2: budesonide-MMX® 6 mg intervention 3: budesonide-MMX® 9 mg intervention 4: Placebo intervention 5: Asacol® 400 mg
Intervention descriptions: intervention 1: Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores intervention 2: 6 mg/day, 6 mg tablets intervention 3: 9 mg/day, 9 mg tablets intervention 4: Placebo intervention 5: 2400 mg/day, 400 mg tablets

Protocol document: