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OpenTrials
Completed

NCT Number: NCT02586259

Effectiveness of Cortiment® in Patients With Ulcerative Colitis

The purpose of this study is to evaluate Cortiment® with regard to its use by clinicians in routine clinical practice and its effectiveness and tolerability in a real-life setting.

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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 and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Digestive Health Clinic (there may be other sites in this country), Richmond Hill, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women aged ≥ 18 years
  • Outpatients
  • Patients who have been prescribed Cortiment® for the treatment of mild to moderate active ulcerative colitis within a 5 days' time window prior to being included in the study
  • Patients who have received adequate information regarding this non-interventional study and are able to understand and voluntarily sign the Informed Consent

Exclusion criteria

  • Patients with severe active / fulminant ulcerative colitis
  • Patients treated with antibiotics or corticosteroids for the current flare. Use of Antibiotics for other conditions non-related to the gastrointestinal tract, either before enrolment or during the observational period is permitted.
  • History of total / sub-total colectomy
  • Hypersensitivity to the active substance, lecithin (derived soya oil, peanut oil) or to any of the excipients
  • Patients enrolled and involved in an interventional study
  • Patients whom investigators consider inappropriate to participate in the study

Treatment and study plan

budesonide MMX®

Drug

Other names: Cortiment®

Primary outcomes

  1. Clinical benefit in routine practice, defined as % of patients with clinical improvement ≥ 3-point in Ulcerative Colitis Disease Activity Index (UCDAI) clinical sub-score

    Time frame: From Day 1 to end of induction treatment (recommended duration up to 8 weeks)

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

A Prospective Multi-centre Observational Cohort Study Assessing the Effectiveness of Cortiment® for the Treatment of Mild-to-moderate Active Ulcerative Colitis in Routine Clinical Practice

Acronym: CORE Practice

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 26, 2015
Registry last updated
Nov 20, 2019

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.

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