Overview
TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)
Status:
Completed
Completed
Trial end date:
2015-06-01
2015-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of the trial is to proof whether TID 1000 mg mesalazine is non-inferior to TID 2x 500 mg mesalazine in the treatment of patients with acute ulcerative colitisPhase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Dr. Falk Pharma GmbHTreatments:
Mesalamine
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
Exclusion Criteria:
- Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis,
diverticular disease associated colitis, microscopic colitis (i.e., collagenous
colitis and lymphocytic colitis)
- Toxic megacolon
- Screening stool positive for germs causing bowel disease
- Malabsorption syndromes
- Celiac disease
- Other inflammatory or bleeding disorders of the colon and intestine, or diseases that
may cause diarrhoea or gastrointestinal bleeding