Profermin® in Active Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— CUPE-1  

Official title:

Safety and Efficacy of Profermin® to Induce Remission in Patients With Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245465
• Other study ID #: H-B-2008-FSP-20
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 18, 2010
• Last updated: November 22, 2010
• Start date: January 2009
• Est. completion date: November 2009

Study information

• Verified date: November 2010
• Source: Nordisk Rebalance A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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 new online daily symptom registration system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

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-

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Profermin
Medical Food (food for special medical purposes)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nordisk Rebalance A/S	Hvidovre University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI =50%.	Daily report of SCCAI symptoms on the Internet	24 weeks	No
Secondary	Our secondary endpoint was to estimate the proportion of patients in remission defined as SCCAI lower than or equal to 2.5	Daily report of SCCAI symptoms on the Internet	24 weeks	No