Mesalazine (PENTASA®) in Ulcerative Colitis

Ferring Pharmaceuticals506 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

506

Conditions

Ulcerative Colitis

Interventions

MesalazineOTHER

Patient's treated with oral Mesalazine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (149)

Outcomes

Primary Outcomes

Patient compliance: Measured by patient response to a questionnaire

Time frame: Month 0 - Month 12

Secondary Outcomes

Patient's level of information: Measured by patient response to a questionnaire

Time frame: Month 0 - Month 12

Patient's preference for the oral pharmaceutical form: Measured by patient response to a questionnaire

Time frame: Month 0 - Month 12

Reasons for the therapeutic decision of the physician: Measured by physician responses

Time frame: Month 0

Laboratory parameters of predefined blood measurements

Faecal calprotectin (including test used), faecal lactoferrin. Number of leukocytes, C-reactive protein, blood sedimentation rate. Haemoglobin, serum iron, serum ferritin, transferrin saturation (TSAT)

Time frame: Month 0- Month 12

Ulcerative Colitis Disease Activity Index (UCDAI)

UCDAI = Blood in stool, stool frequency, overall evaluation of the physician, endoscopic evaluation (optional)

Time frame: Month 0 - Month 12

Adverse drug reactions: measured by number of patients and event severity

Time frame: Month 0 - Month 12

Data from ClinicalTrials.gov

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Investigational site, Wettinerstraße 22

Altenburg, Germany

Investigational site, Marienstraße 6

Amberg, Germany

Investigational site, Adam-Ries-Straße 57c

Annaberg-Buchholz, Germany

Investigational site, Goethestraße 5

Ansbach, Germany

Investigational site, Elisenstraße 32

Aschaffenburg, Germany

Investigational site, Prinzregentenstraße 8

Augsburg, Germany

Investigational site, Koblenzer Straße 37

Bad Godesberg, Germany

Investigational site, Goethestraße 15g

Bad Neustadt an der Saale, Germany

Investigational site, Töpferstraße 17

Bautzen, Germany

Investigational site, Bahnhofstraße 18

Berlin, Germany

...and 139 more locations