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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 week

Number 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

Page last updated: August 23, 2015

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