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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02586259 |
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Date of registration:
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23/10/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effectiveness of Cortiment® in Patients With Ulcerative Colitis
CORE Practice |
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Scientific title:
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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 |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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378 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02586259 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Germany
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Ireland
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Israel
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Italy
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Netherlands
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Poland
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Sweden
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Switzerland
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United Kingdom
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Contacts
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Name:
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Global Clinical Compliance |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ferring Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: budesonide MMX®
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Primary Outcome(s)
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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)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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