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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 June 2016 |
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Main ID: |
NCT01745770 |
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Date of registration:
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05/12/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC)
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Scientific title:
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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 |
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Date of first enrolment:
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January 2013 |
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Target sample size:
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306 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01745770 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Active Ulcerative Colitis
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Intervention(s)
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Drug: Mesalazine - TID 2x 500 mg
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Drug: Mesalazine - TID 1000 mg
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Primary Outcome(s)
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Rate of clinical remission
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Number of stools per week
[Time Frame: 8 weeks]
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Number of bloody stools per week
[Time Frame: 8 weeks]
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Time to first resolution of clinical symptoms
[Time Frame: 8 weeks]
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Secondary ID(s)
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SAT-25/UCA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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