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

Exclusion Criteria

• •Patients who meet any of the following criteria at screening visit are to be excluded from study participation:
• •* Patients with limited distal proctitis (from anal verge up to 15 cm above the pectineal line).
• •* Patients with severe ulcerative colitis (UCDAI \>10).
• •* Patients with infectious colitis.
• •* Evidence or history of toxic megacolon.
• •* Severe anaemia, leucopaenia or granulocytopaenia.
• •* Use of oral or rectal steroids in the last 4 weeks.
• •* Use of immuno-suppressive agents in the last 8 weeks before the study.
• •* Use of anti tumour necrosis factor alpha (anti-TNFα) agents in the last 3 months.
• •* Concomitant use of any rectal preparation.
• •* Concomitant use of antibiotics.
• •* Concurrent use of cytochrome P450 3A4 (CYP3A4) inducers or CYP3A4 inhibitors.
• •* Patients with verified, presumed or expected pregnancy or ongoing lactation.
• •* Patients with liver cirrhosis, or evident hepatic or renal disease or insufficiency, and/or severe impairment of the bio-humoural parameters (i.e. 2 x upper limit of normal for alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT) or creatinine).
• •* Patient with severe diseases in other organs and systems.
• •* Patients with local or systemic complications or other pathological states requiring a therapy with corticosteroids and/or immuno-suppressive agents.
• •* Patients diagnosed with type 1 diabetes.
• •* Patients diagnosed with, or with a family history of, glaucoma.
• •* All patients with known hepatitis B, hepatitis C or with human immunodeficiency virus (HIV), according to the local privacy policy.
• •* Participation in experimental therapeutic studies in the last 3 months. (Note: patients who participated in observational only studies are not excluded).
• •* Any other medical condition that in the principal investigator's opinion would make the administration of the study drug or study procedures hazardous to the subject or obscure the interpretation of adverse events (AEs).