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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01245465 |
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Date of registration:
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18/11/2010 |
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Primary sponsor: |
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Public title:
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Profermin® in Active Ulcerative Colitis
CUPE-1 |
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Scientific title:
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Safety and Efficacy of Profermin® to Induce Remission in Patients With Ulcerative Colitis |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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39 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01245465 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Hans Israelsen, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nordisk Rebalance A/S |
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Key inclusion & exclusion criteria
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Inclusion Criteria:Patients were eligible if they were between 18 and 50 years of age and
had an established diagnosis of UC based on clinical, endoscopic and histological
features. Active disease was assessed by Simple Clinical Colitis Activity Index (SCCAI)
(Table 1) score above 4 and below 12.
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Exclusion Criteria:
Patients who initiated treatment with azathioprine, 6-mercaptopurine, ciclosporin or
methotrexate within 8 weeks prior to inclusion or TNF-a inhibitors within 12 weeks before
inclusion or had changes in UC treatment within 2 weeks before inclusion were ineligible
for the study. Concomitant coeliac disease or lactose intolerance were also exclusion
criteria. In addition any malignant or premalignant condition or recent gastroenteritis
rendered patients ineligible-
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Other: Profermin
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Primary Outcome(s)
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Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI =50%.
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Our secondary endpoint was to estimate the proportion of patients in remission defined as SCCAI lower than or equal to 2.5
[Time Frame: 24 weeks]
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Secondary ID(s)
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H-B-2008-FSP-20
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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