Mesalazine (PENTASA®) in Ulcerative Colitis (MUKOSA)

September 30, 2015 updated by: Ferring Pharmaceuticals

Mesalazine (PENTASA®) in Ulcerative Colitis: Correlation of the Information Level With Patient's Compliance in Everyday Practice

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

506

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Altenburg, Germany
        • Investigational site, Wettinerstraße 22
      • Amberg, Germany
        • Investigational site, Marienstraße 6
      • Annaberg-Buchholz, Germany
        • Investigational site, Adam-Ries-Straße 57c
      • Ansbach, Germany
        • Investigational Site, Goethestraße 5
      • Aschaffenburg, Germany
        • Investigational Site, Elisenstraße 32
      • Augsburg, Germany
        • Investigational site, Prinzregentenstraße 8
      • Bad Godesberg, Germany
        • Investigational site, Koblenzer Straße 37
      • Bad Neustadt, Germany
        • Investigational site, Goethestraße 15g
      • Bautzen, Germany
        • Investigational site, Töpferstraße 17
      • Berlin, Germany
        • Investigational site, Ehrenfelsstraße 47
      • Berlin, Germany
        • Investigational Site, Hohenzollerndamm 47a
      • Berlin, Germany
        • Investigational site, Bahnhofstraße 18
      • Berlin, Germany
        • Investigational Site, Blankenburger Chaussee 86
      • Berlin, Germany
        • Investigational site, Bundesallee 104-105
      • Berlin, Germany
        • Investigational Site, Etkar-André-Straße 8
      • Berlin, Germany
        • Investigational site, Innsbrucker Straße 58
      • Berlin, Germany
        • Investigational site, Klosterstraße 34
      • Berlin, Germany
        • Investigational site, Kurfürstendamm 42
      • Berlin, Germany
        • Investigational Site, Mohrenstraße 6
      • Berlin, Germany
        • Investigational Site, Myslowitzer Straße 49
      • Berlin, Germany
        • Investigational site, Schönhauser Allee 118
      • Berlin, Germany
        • Investigational Site, Schönhauser Allee 129
      • Berlin, Germany
        • Investigational site, Schönstraße 90
      • Berlin, Germany
        • Investigational site, Treskowallee 99
      • Bielefeld, Germany
        • Investigational site, Hauptstraße 88
      • Bietigheim-Bissingen, Germany
        • Investigational site, Hauptstraße 9
      • Bonn, Germany
        • Investigational site, Kasernenstraße 22-24
      • Bonn, Germany
        • Investigational Site, Münsterstraße 18
      • Borken, Germany
        • Investigational site, Propst-Sievert-Weg 9
      • Brandenburg/Havel, Germany
        • Investigational site, Trauerberg 27-28
      • Butzbach, Germany
        • Investigational site, Wetzlarer Straße 22
      • Calw, Germany
        • Investigational Site, Hermann-Hesse-Platz 3
      • Castrop-Rauxl, Germany
        • Investigational site, Dortmunder Straße
      • Chemnitz, Germany
        • Investigational site, Hainstraße 112
      • Cottbus, Germany
        • Investigational site, Bahnhofstraße 64
      • Cottbus, Germany
        • Investigational site, Vetschauer Straße 11a
      • Darmstadt, Germany
        • Investigational site, Frankfurter Straße 3
      • Darmstadt, Germany
        • Investigational site, Rheinstraße 44-46
      • Detmold, Germany
        • Investigational site, Lagesche Straße 19
      • Dingolfing, Germany
        • Investigational site, Jahnstraße 1
      • Dinkelsbühl, Germany
        • Investigational site, Karlsbader Straße 7
      • Dorsten, Germany
        • Investigational site, Recklinghäuser Straße 14
      • Dortmund, Germany
        • Investigational site, Rheinlanddamm 10
      • Dresden, Germany
        • Investigational site, Lukasstraße 3
      • Dresden, Germany
        • Investigational site, Rehefelder Straße 12
      • Eisenach, Germany
        • Investigational site, Mühlhäuser Straße 94, Haus F
      • Ellefeld, Germany
        • Investigational site, Winkelgasse 1
      • Elmshorn, Germany
        • Investigational site, Königstraße 12-14
      • Engelskirchen, Germany
        • Investigational site, Märkischestraße 30
      • Erftstadt, Germany
        • Investigational site, Franz-Busbach-Straße 8
      • Erfurt, Germany
        • Investigational Site, Neuwerkstraße 2
      • Essen, Germany
        • Investigational site, Ruhrallee 81
      • Euskirchen, Germany
        • Investigational Site, Viktoriastraße 5
      • Frankfurt, Germany
        • Investigational Site, Im Prüfling 23
      • Frankfurt Main, Germany
        • Investigational site, Hochstraße 43
      • Frankfurt Main, Germany
        • Investigational site, Pfingsweidstraße 4
      • Frankfurt Main, Germany
        • Investigational site, Stresemannallee 3
      • Freiburg, Germany
        • Investigational site, Habsburgerstraße 105
      • Friedrichshafen, Germany
        • Investigational site, Schnetzenhauser Straße 5
      • Fürth, Germany
        • Investigational site, Moststraße 19
      • Gardelegen, Germany
        • Investigational site, Gartenstraße 29
      • Garmisch-Partenkirchen, Germany
        • Investigational site, Hauptstraße 60-64
      • Gehrden, Germany
        • Investigational site, Am Markt 3
      • Gelsenkirchen, Germany
        • Investigational site, In der Heide 19
      • Gelsenkirchen, Germany
        • Investigational site, Von-der-Recke-Straße 14
      • Gilching, Germany
        • Investigational site, Pollinger Straße 23
      • Grevenbroich, Germany
        • Investigational site, Von-Werth-Straße 5
      • Gütersloh, Germany
        • Investigational site, Avenwedder Straße 50
      • Hachelweg 19, Germany
        • Investigational site, Hachelweg 19
      • Hachingen, Germany
        • Investigational site, Fürstin-Eugenie-Straße 7
      • Hagen, Germany
        • Investigational site, Buscheystraße 15a
      • Hamburg, Germany
        • Investigational Site, Eppendorfer Baum 35-37
      • Hamburg, Germany
        • Investigational site, Eppendorfer Landstraße 42
      • Hamburg, Germany
        • Investigational site, Fontenay 1d
      • Hamburg, Germany
        • Investigational site, Harksheider Straße 3
      • Hamburg, Germany
        • Investigational site, Schlossstrasse 44
      • Hamburg, Germany
        • Investigational site, Schäferkampsallee 56-58
      • Hamm, Germany
        • Investigational site, Sudetenweg 6
      • Heilbronn, Germany
        • Investigational site, Staufenbergstraße 31
      • Hennef, Germany
        • Investigational site, Frankfurter Straße 100a
      • Herne, Germany
        • Investigational site, Am Ruschenhof 24
      • Herne, Germany
        • Investigational site, Wiescherstraße 20
      • Herrsching, Germany
        • Investigational site, Seestraße 43
      • Iserlohn, Germany
        • Investigational site, Waisenhausstraße 2
      • Jerichow, Germany
        • Investigational site, J.-Lange-straße 20
      • Jever, Germany
        • Investigational site, Prinzenallee 10
      • Karlsruhe, Germany
        • Investigational site, Hans-Sachs-Straße 1
      • Karlstadt, Germany
        • Investigational site, Am Tiefen Weg 2
      • Kassel, Germany
        • Investigational site, Opernstraße 9
      • Kiel, Germany
        • Investigational site, Feldstraße 5-7
      • Kitzingen, Germany
        • Investigational site, Moltkestraße 9
      • Köln, Germany
        • Investigational site, Graseggerstraße 105
      • Köln, Germany
        • Investigational site, Venloer Straße 247
      • Königstein, Germany
        • Investigational Site, Herzog-Adolph-Straße 13
      • Köthen, Germany
        • Investigational site, Schalaunische Straße 6-7
      • Landshut, Germany
        • Investigational site, Dreifaltigkeitsplatz 177
      • Langen, Germany
        • Investigational site, Röntgenstraße 6-8
      • Leipzig, Germany
        • Investigational site, Funkenburgstraße 19
      • Leipzig, Germany
        • Investigational site, Johannisplatz 1
      • Leisnig, Germany
        • Investigational site, Markt 3
      • Leverkusen, Germany
        • Investigational site, Am Gesundheitspark 11
      • Ludwigshafen, Germany
        • Investigational site, Yorckstraße 1
      • Lutherstadt Wittenberg, Germany
        • Investigational site, Berliner Straße 8
      • Lübeck, Germany
        • Investigational site, Kronsforder Allee 19
      • Lübeck, Germany
        • Investigational site, Kronsforder Allee 69
      • Mannheim, Germany
        • Investigational site, Bismarckplatz 1
      • Mechernich, Germany
        • Investigational site, Stiftsweg 17
      • München, Germany
        • Investigational site, Am Harras 2
      • München, Germany
        • Investigational Site, Irisstraße 23
      • München, Germany
        • Investigational site, Kaulbachstraße 61
      • München, Germany
        • Investigational site, Maximilianstraße 16
      • München, Germany
        • Investigational site, Schönfeldstraße 16
      • Neumarkt, Germany
        • Investigational site, Unterer Markt 26-27
      • Neuwied, Germany
        • Investigational site, Hofgründchen 13
      • Nürnberg, Germany
        • Investigational Site, Am Stadtpark 2
      • Nürnberg, Germany
        • Investigational Site, Glogauer Straße 42
      • Nürnberg, Germany
        • Investigational Site, Weiltinger Straße 11
      • Oldenburg, Germany
        • Investigational site, Hauptstraße 36
      • Oldenburg, Germany
        • Investigational site, Neue Donnerschweer Straße 30
      • Oldenburg, Germany
        • Investigational site, Ofener Straße 30
      • Osnabrück, Germany
        • Investigational site, Bramscher Straße 242
      • Paderborn, Germany
        • Investigational site, Le-Mans-Wall 5
      • Paderborn, Germany
        • Investigational site, Westendstraße 38
      • Papenburg, Germany
        • Investigational site, Haptkanal rechts 75
      • Plauen, Germany
        • Investigational site, Neundorfer Straße 14
      • Potsdam, Germany
        • Investigational site, Allee nach Sanccouci 7
      • Potsdam, Germany
        • Investigational Site, Großbeerenstraße 301
      • Potsdam, Germany
        • Investigational Site, R.-Breitscheid-Straße 56
      • Radevormwald, Germany
        • Investigational site, Kaiserstraße 166
      • Reinsdorf, Germany
        • Investigational site, Neue Straße 34
      • Rheinbach, Germany
        • Investigational site, Keramikerstraße 61
      • Rostock, Germany
        • Investigational site, St.-Petersburger-straße 18c
      • Rottach-Weissach, Germany
        • Investigational site, Tegernseerstraße 100
      • Rottenburg, Germany
        • Investigational site, Marktplatz 23
      • Schmalkalden, Germany
        • Investigational site, Waldhausstraße 13
      • Schwalmstadt, Germany
        • Investigational site, Krankenhausstraße 20
      • Singen, Germany
        • Investigational site, Virchowstraße 10c
      • Stade, Germany
        • Investigational site, Wallstraße 38
      • Stuttgart, Germany
        • Investigational Site, Am Wallgraben 99
      • Sundern, Germany
        • Investigational Site, Röhre 1
      • Teuchern, Germany
        • Investigational site, Straße des Friedens 34c
      • Uelzen, Germany
        • Investigational site, Hambrocker Straße 53
      • Vahingen, Germany
        • Investigational site, Andreaestraße 16/1
      • Waltrop, Germany
        • Investigational site, Hochstraße 20
      • Waren, Germany
        • Investigational site, Kletzstraße 13B
      • Weilheim, Germany
        • Investigational site, Fischergasse 16
      • Wesel, Germany
        • Investigational site, Julius-Leber-Strasße 8
      • Wesseling, Germany
        • Investigational site, Westring 14
      • Wetzlar, Germany
        • Investigational site, Forsthausstraße 1e

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care facilities

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mesalazine
Other: Mesalazine
Patient's treated with oral Mesalazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient compliance: Measured by patient response to a questionnaire
Time Frame: Month 0 - Month 12
Month 0 - Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's level of information: Measured by patient response to a questionnaire
Time Frame: Month 0 - Month 12
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
Month 0 - Month 12
Reasons for the therapeutic decision of the physician: Measured by physician responses
Time Frame: Month 0
Month 0
Laboratory parameters of predefined blood measurements
Time Frame: 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)
Month 0- Month 12
Ulcerative Colitis Disease Activity Index (UCDAI)
Time Frame: Month 0 - Month 12
UCDAI = Blood in stool, stool frequency, overall evaluation of the physician, endoscopic evaluation (optional)
Month 0 - Month 12
Adverse drug reactions: measured by number of patients and event severity
Time Frame: Month 0 - Month 12
Month 0 - Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Collaborators

Ferring Arzneimittel GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 20, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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