NCT01517607CompletedNot Applicable
Mesalazine (PENTASA®) in Ulcerative Colitis: Correlation of the Information Level With Patient's Compliance in Everyday Practice
Ferring Pharmaceuticals149 sites in 1 country506 target enrollmentStarted: February 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 506
- Locations
- 149
- Primary Endpoint
- Patient compliance: Measured by patient response to a questionnaire
Study Overview
Brief Summary
This non-interventional study examines whether the patient's level of information and the consideration of the patient's preference have a positive effect on the compliance and thus also on the therapeutic success.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Patient compliance: Measured by patient response to a questionnaire
Time Frame: Month 0 - Month 12
Secondary Outcomes
- Reasons for the therapeutic decision of the physician: Measured by physician responses(Month 0)
- Patient's preference for the oral pharmaceutical form: Measured by patient response to a questionnaire(Month 0 - Month 12)
- Ulcerative Colitis Disease Activity Index (UCDAI)(Month 0 - Month 12)
- Laboratory parameters of predefined blood measurements(Month 0- Month 12)
- Patient's level of information: Measured by patient response to a questionnaire(Month 0 - Month 12)
- Adverse drug reactions: measured by number of patients and event severity(Month 0 - Month 12)
Investigators
Study Sites (149)
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