Budesonide 9 mg Capsules in Active UC

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Falk Pharma GmbH
• Treatments: Budesonide

Criteria

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