Trial on Profermin and Fresubin in Ulcerative Colitis (CUPE2)

December 16, 2013 updated by: Nordisk Rebalance A/S

A Randomized Trial on Profermin and Fresubin for Dietetic Treatment of Active Ulcerative Colitis

This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital region
      • Allerod, Capital region, Denmark, 3450
        • Noreba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Active ulcerative colitis (SCCAI =>5 and <=11)
  • Access to Internet

Exclusion Criteria:

  • Stoma or intestinal resections
  • Recent changes in UC medication
  • Treatment with antibiotics
  • Diabetes
  • Celiac disease
  • Lactose malabsorption

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Profermin
Other: Profermin
Medical Food (food for special medical purposes)
Active Comparator: Fresubin
Other: Fresubin
Medical food (food for special medical purposes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development in Simple Clinical Colitis Activity Index (SCCAI) score
Time Frame: 8 and 16 weeks
Clinical significant difference (>1.5) in course of SCCAI score between the two intervention groups
8 and 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in SCCAI score
Time Frame: 8 and 16 weeks
Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5
8 and 16 weeks
Clinical remission
Time Frame: 8 and 16 weeks
Proportion of patients in clinical remission (SCCAI=<2.5)
8 and 16 weeks
Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 20 weeks
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordisk Rebalance A/S

Collaborators

Hvidovre University Hospital

Investigators

  • Study Director: Hans Israelsen, PhD, Nordisk Rebalance A/S
  • Principal Investigator: Aleksander Krag, MD, PhD, Hvidovre University Hospital
  • Study Chair: Flemming Bendtsen, MD, DMSci, Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 23, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (Estimate)

September 2, 2010

Study Record Updates

Last Update Posted (Estimate)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 16, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUPE2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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