TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)
NCT ID: NCT01745770
Last Updated: 2016-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
306 participants
INTERVENTIONAL
2013-01-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Mesalazine - TID 1000 mg
B
Mesalazine - TID 2x 500 mg
Interventions
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Mesalazine - TID 1000 mg
Mesalazine - TID 2x 500 mg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Dr. Falk Pharma GmbH
INDUSTRY
Responsible Party
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Locations
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Med. Klinik 1 - Markus-Krankenhaus
Frankfurt am Main, Hesse, Germany
Countries
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Other Identifiers
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SAT-25/UCA
Identifier Type: -
Identifier Source: org_study_id
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