['colitis, ulcerative']
['budesonide']

        Inclusion Criteria:

          -  Signed informed consent,

          -  Men or women aged 18 to 75 years,

          -  Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by
             endoscopy and histology,

          -  Established disease,

        Exclusion Criteria:

          -  Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis,
             microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete
             microscopic colitis), diverticular disease associated colitis,

          -  Toxic megacolon or fulminant colitis,

          -  Colon resection,

          -  Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile
             toxin in stool culture at screening),

          -  Malabsorption syndromes,

          -  Celiac disease,

          -  Bleeding hemorrhoids,

          -  Active peptic ulcer disease

          -  Other inflammatory or bleeding disorders of the colon and intestine, or diseases that
             may cause diarrhea or gastrointestinal bleeding,

          -  Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma,
             cataract, or infection if careful medical monitoring is not ensured,

          -  Any severe infectious disease (e.g., tuberculosis, AIDS),

          -  Severe co-morbidity substantially reducing life expectancy,

          -  History of colorectal cancer,

          -  History of cancer (other than colorectal) in the last 5 years, except for basal cell
             carcinoma
      