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Profermin® in Active Ulcerative Colitis (CUPE-1)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Profermin
Sponsored by
Nordisk Rebalance A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Profermin

    Arm Description

    Daily oral intake of a food for special medical purposes (Profermin)

    Outcomes

    Primary Outcome Measures

    Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%.
    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
    Daily report of SCCAI symptoms on the Internet

    Full Information

    First Posted
    November 18, 2010
    Last Updated
    November 22, 2010
    Sponsor
    Nordisk Rebalance A/S
    Collaborators
    Hvidovre University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01245465
    Brief Title
    Profermin® in Active Ulcerative Colitis
    Acronym
    CUPE-1
    Official Title
    Safety and Efficacy of Profermin® to Induce Remission in Patients With Ulcerative Colitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Nordisk Rebalance A/S
    Collaborators
    Hvidovre University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 new online daily symptom registration system.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Profermin
    Arm Type
    Experimental
    Arm Description
    Daily oral intake of a food for special medical purposes (Profermin)
    Intervention Type
    Other
    Intervention Name(s)
    Profermin
    Intervention Description
    Medical Food (food for special medical purposes)
    Primary Outcome Measure Information:
    Title
    Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%.
    Description
    Daily report of SCCAI symptoms on the Internet
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    Our secondary endpoint was to estimate the proportion of patients in remission defined as SCCAI lower than or equal to 2.5
    Description
    Daily report of SCCAI symptoms on the Internet
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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. - 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-
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hans Israelsen, PhD
    Organizational Affiliation
    Nordisk Rebalance A/S
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Profermin® in Active Ulcerative Colitis

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