NCT01245465

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
Last Updated

November 23, 2010

Status Verified

November 1, 2010

Enrollment Period

10 months

First QC Date

November 18, 2010

Last Update Submit

November 22, 2010

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Our secondary endpoint was to estimate the proportion of patients in remission defined as SCCAI lower than or equal to 2.5

    24 weeks

Study Arms (1)

Profermin

EXPERIMENTAL

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

Other: Profermin

Interventions

ProferminOTHER

Medical Food (food for special medical purposes)

Profermin

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

profermin

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Hans Israelsen, PhD

    Nordisk Rebalance A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 22, 2010

Study Start

January 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

November 23, 2010

Record last verified: 2010-11