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Profermin® in Active Ulcerative Colitis (CUPE-1)

This study has been completed.
Sponsor:
Collaborator:
Hvidovre University Hospital
Information provided by:
Nordisk Rebalance A/S
ClinicalTrials.gov Identifier:
NCT01245465
First received: November 18, 2010
Last updated: November 22, 2010
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
 Other: Profermin
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Profermin® to Induce Remission in Patients With Ulcerative Colitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nordisk Rebalance A/S:

Primary Outcome Measures:
  • Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Daily report of SCCAI symptoms on the Internet


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Daily report of SCCAI symptoms on the Internet


Enrollment: 39
Study Start Date: January 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Profermin
Daily oral intake of a food for special medical purposes (Profermin)
 Other: Profermin
Medical Food (food for special medical purposes)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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-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-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245465

Sponsors and Collaborators
Nordisk Rebalance A/S
Hvidovre University Hospital
Investigators
Study Director: Hans Israelsen, PhD Nordisk Rebalance A/S
  More Information

No publications provided

Responsible Party: Hans Israelsen, Noreba
ClinicalTrials.gov Identifier: NCT01245465     History of Changes
Other Study ID Numbers: H-B-2008-FSP-20
Study First Received: November 18, 2010
Last Updated: November 22, 2010
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013