Effectiveness of Cortiment® in Patients With Ulcerative Colitis
NCT ID: NCT02586259
Last Updated: 2019-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
378 participants
OBSERVATIONAL
2015-12-31
2018-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cortiment®
Treatment according to routine clinical practice.
budesonide MMX®
Interventions
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budesonide MMX®
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Digestive Health Clinic (there may be other sites in this country)
Richmond Hill, , Canada
Magen-Darm-Zentrum, Facharztzentrum Eppendorf (there may be other sites in this country)
Hamburg, , Germany
St. Vincent's University Hospital (there may be other sites in this country)
Dublin, , Ireland
Investigational site (there may be other sites in this country)
Bologna, , Italy
Investigational site (there may be other sites in this country)
Amsterdam, , Netherlands
Investigational site (there may be other sites in this country)
Warsaw, , Poland
Danderyds sjukhus (there may be other sites in this country)
Stockholm, , Sweden
Kings College Hospital (there may be other sites in this country)
London, , United Kingdom
Countries
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References
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Danese S, Hart A, Dignass A, Fiorino G, Louis E, Bonovas S, D'Haens G, Dotan I, Rogler G, Paridaens K, Peyrin-Biroulet L. A multicentre prospective cohort study assessing the effectiveness of budesonide MMX(R) (Cortiment(R)MMX(R)) for active, mild-to-moderate ulcerative colitis. United European Gastroenterol J. 2019 Nov;7(9):1171-1182. doi: 10.1177/2050640619864848. Epub 2019 Jul 17.
Danese S, Hart A, Dignass A, Louis E, D'Haens G, Dotan I, Rogler G, D'Agay L, Iannacone C, Peyrin-Biroulet L. Effectiveness of budesonide MMX (Cortiment) for the treatment of mild-to-moderate active ulcerative colitis: study protocol for a prospective multicentre observational cohort study. BMJ Open Gastroenterol. 2016 May 17;3(1):e000092. doi: 10.1136/bmjgast-2016-000092. eCollection 2016.
Other Identifiers
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000217
Identifier Type: -
Identifier Source: org_study_id
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