Profermin® in Active Ulcerative Colitis (CUPE-1)

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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Other: Profermin

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Profermin; Daily oral intake of a food for special medical purposes (Profermin)	Other: Profermin; Medical Food (food for special medical purposes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nordisk Rebalance A/S
• Collaborators: Hvidovre University Hospital
• Investigators: Study Director: Hans Israelsen, PhD, Nordisk Rebalance A/S

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: November 18, 2010
• First Submitted That Met QC Criteria: November 19, 2010
• First Posted (Estimate): November 22, 2010

Study Record Updates

• Last Update Posted (Estimate): November 23, 2010
• Last Update Submitted That Met QC Criteria: November 22, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: H-B-2008-FSP-20