Overview

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