Profermin® in Active 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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-

Treatment and study plan

Profermin

Other

Medical Food (food for special medical purposes)

Primary outcomes

Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%.

Time frame: 24 weeks

Daily report of SCCAI symptoms on the Internet

Secondary outcomes

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

Daily report of SCCAI symptoms on the Internet

Sponsors and collaborators

Lead sponsor

Nordisk Rebalance A/S

Industry

Collaborators

Hvidovre University Hospital

Registry information

Official study title

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

Acronym: CUPE-1

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Nov 22, 2010
Registry last updated: Nov 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed