Status:
COMPLETED
Profermin® in Active Ulcerative Colitis
Lead Sponsor:
Nordisk Rebalance A/S
Collaborating Sponsors:
Hvidovre University Hospital
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
In this study the investigators aim was to investigate the safety and possible efficacy of Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the usefulness of a...
Eligibility Criteria
Inclusion
- 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
- Patients who initiated treatment with azathioprine, 6-mercaptopurine, ciclosporin or methotrexate within 8 weeks prior to inclusion or TNF-α 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-
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01245465
Start Date
January 1 2009
End Date
November 1 2009
Last Update
November 23 2010
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