Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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
Brief 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.


Options:
A: Arm Label: 1: budesonide-MMX® 6 mg; Type: EXPERIMENTAL; Interventions: Procedure: Blood sampling, endoscopy, Drug: Budesonide MMX® 6 mg | Arm Label: 2: budesonide-MMX® 9 mg; Type: EXPERIMENTAL; Interventions: Procedure: Blood sampling, endoscopy, Drug: Budesonide MMX® 9 mg | Arm Label: 3: Entocort EC® 3 mg; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Blood sampling, endoscopy, Drug: Entocort EC® 3 mg | Arm Label: 4: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Blood sampling, endoscopy, Drug: Placebo | Intervention Type: PROCEDURE; Name: Blood sampling, endoscopy; Assigned to Arm(s): 1: budesonide-MMX® 6 mg, 2: budesonide-MMX® 9 mg, 3: Entocort EC® 3 mg, 4: Placebo | Intervention Type: DRUG; Name: Budesonide MMX® 6 mg; Assigned to Arm(s): 1: budesonide-MMX® 6 mg | Intervention Type: DRUG; Name: Budesonide MMX® 9 mg; Assigned to Arm(s): 2: budesonide-MMX® 9 mg | Intervention Type: DRUG; Name: Entocort EC® 3 mg; Assigned to Arm(s): 3: Entocort EC® 3 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 4: Placebo
B: Intervention Type: DRUG; Name: Infliximab; Assigned to Arm(s): N/A
C: Arm Label: 1: budesonide-MMX® 6 mg; Type: EXPERIMENTAL; Interventions: Procedure: Blood sampling, endoscopy, Drug: budesonide-MMX® 6 mg | Arm Label: 2: budesonide-MMX® 9 mg; Type: EXPERIMENTAL; Interventions: Procedure: Blood sampling, endoscopy, Drug: budesonide-MMX® 9 mg | Arm Label: 3: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Blood sampling, endoscopy, Drug: Placebo | Arm Label: 4: Asacol® 400 mg; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Blood sampling, endoscopy, Drug: Asacol® 400 mg | Intervention Type: PROCEDURE; Name: Blood sampling, endoscopy; Assigned to Arm(s): 1: budesonide-MMX® 6 mg, 2: budesonide-MMX® 9 mg, 3: Placebo, 4: Asacol® 400 mg | Intervention Type: DRUG; Name: budesonide-MMX® 6 mg; Assigned to Arm(s): 1: budesonide-MMX® 6 mg | Intervention Type: DRUG; Name: budesonide-MMX® 9 mg; Assigned to Arm(s): 2: budesonide-MMX® 9 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 3: Placebo | Intervention Type: DRUG; Name: Asacol® 400 mg; Assigned to Arm(s): 4: Asacol® 400 mg
D: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: budesonide | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: mesalazine | Intervention Type: DRUG; Name: budesonide; Assigned to Arm(s): A | Intervention Type: DRUG; Name: mesalazine; Assigned to Arm(s): B

Answer: A