TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)

Last updated: May 30, 2016
Sponsor: Dr. Falk Pharma GmbH
Overall Status: Completed

Phase

3

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT01745770
SAT-25/UCA
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 byendoscopy and histology

Exclusion

Exclusion Criteria:

  • Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis,diverticular disease associated colitis, microscopic colitis (i.e., collagenouscolitis 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 thatmay cause diarrhoea or gastrointestinal bleeding

Study Design

Total Participants: 306
Study Start date:
January 01, 2013
Estimated Completion Date:
June 30, 2015

Connect with a study center

  • Med. Klinik 1 - Markus-Krankenhaus

    Frankfurt, Hessen 60431
    Germany

    Site Not Available

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