Mesalazine (PENTASA®) in Ulcerative Colitis

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT01517607
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-20
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Study Start: 2012-02
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 506

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient compliance: Measured by patient response to a questionnaire	Month 0 - Month 12

Secondary Outcome Measures

Name	Time	Method
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	UCDAI = Blood in stool, stool frequency, overall evaluation of the physician, endoscopic evaluation (optional)
Laboratory parameters of predefined blood measurements	Month 0- Month 12	Faecal calprotectin (including test used), faecal lactoferrin. Number of leukocytes, C-reactive protein, blood sedimentation rate. Haemoglobin, serum iron, serum ferritin, transferrin saturation (TSAT)
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

Trial Locations

Locations (149)

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, Germany

Investigational site, Töpferstraße 17; 🇩🇪 Bautzen, Germany

Investigational site, Bahnhofstraße 18; 🇩🇪 Berlin, Germany

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