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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 October 2015 |
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Main ID: |
NCT01517607 |
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Date of registration:
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20/01/2012 |
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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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Mesalazine (PENTASA®) in Ulcerative Colitis
MUKOSA |
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Scientific title:
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Mesalazine (PENTASA®) in Ulcerative Colitis: Correlation of the Information Level With Patient's Compliance in Everyday Practice |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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506 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01517607 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Clinical Development Support |
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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:
- Patients are treated for the first time with oral PENTASA®, e.g. following first
diagnosis of ulcerative colitis for treatment of an acute episode or
- Following a therapy-free period (no previous mesalazine therapy) or due to poor
response or underdosage oder lacking acceptance of the previous medication the
patients are re-adjusted to oral PENTASA®,
- The patients (= 18 years) have been informed about the NIS and have given their
written consent for participation.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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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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Other: Mesalazine
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Primary Outcome(s)
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Patient compliance: Measured by patient response to a questionnaire
[Time Frame: Month 0 - Month 12]
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Secondary Outcome(s)
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Reasons for the therapeutic decision of the physician: Measured by physician responses
[Time Frame: Month 0]
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Patient's level of information: Measured by patient response to a questionnaire
[Time Frame: Month 0 - Month 12]
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Laboratory parameters of predefined blood measurements
[Time Frame: Month 0- Month 12]
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Ulcerative Colitis Disease Activity Index (UCDAI)
[Time Frame: Month 0 - Month 12]
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Adverse drug reactions: measured by number of patients and event severity
[Time Frame: Month 0 - Month 12]
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Patient's preference for the oral pharmaceutical form: Measured by patient response to a questionnaire
[Time Frame: Month 0 - Month 12]
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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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