TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)
Information source: Dr. Falk Pharma GmbH
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Active Ulcerative Colitis
Intervention: Mesalazine - TID 1000 mg (Drug); Mesalazine - TID 2x 500 mg (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Dr. Falk Pharma GmbH
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 colitis
Clinical Details
Official title: Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With Three Times Daily 1000 mg Mesalazine Versus Three Times Daily 2x500 mg Mesalazine in Patients With Active Ulcerative Colitis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Rate of clinical remission
Secondary outcome: Number of stools per weekNumber of bloody stools per week Time to first resolution of clinical symptoms
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Med. Klinik 1 - Markus-Krankenhaus, Frankfurt, Hessen 60431, Germany
Additional Information
Starting date: January 2013
Last updated: March 23, 2015
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