Budesonide 9 mg Capsules in Active UC

Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis

The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis

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