Mesalazine (PENTASA®) in Ulcerative Colitis
MUKOSA
1 other identifier
observational
506
1 country
149
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
149 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2012
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedOctober 1, 2015
September 1, 2015
1.8 years
January 20, 2012
September 30, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Patient compliance: Measured by patient response to a questionnaire
Month 0 - Month 12
Secondary Outcomes (6)
Patient's level of information: Measured by patient response to a questionnaire
Month 0 - Month 12
Patient's preference for the oral pharmaceutical form: Measured by patient response to a questionnaire
Month 0 - Month 12
Reasons for the therapeutic decision of the physician: Measured by physician responses
Month 0
Laboratory parameters of predefined blood measurements
Month 0- Month 12
Ulcerative Colitis Disease Activity Index (UCDAI)
Month 0 - Month 12
- +1 more secondary outcomes
Study Arms (1)
Mesalazine
Interventions
Eligibility Criteria
Primary care facilities
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ferring Pharmaceuticalslead
- Ferring Arzneimittel GmbHcollaborator
Study Sites (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 an der Saale, Germany
Investigational site, Töpferstraße 17
Bautzen, Germany
Investigational site, Bahnhofstraße 18
Berlin, Germany
Investigational site, Blankenburger Chaussee 86
Berlin, Germany
Investigational site, Bundesallee 104-105
Berlin, Germany
Investigational site, Ehrenfelsstraße 47
Berlin, Germany
Investigational site, Etkar-Andre-Straße 8
Berlin, Germany
Investigational site, Hohenzollerndamm 47a
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
Berlin, Germany
Investigational site, Hauptstraße 88
Bielefeld, Germany
Investigational site, Hauptstraße 9
Bietigheim-Bissingen, Germany
Investigational site, Kasernenstraße 22-24
Bonn, Germany
Investigational site, Münsterstraße 18
Bonn, Germany
Investigational site, Propst-Sievert-Weg 9
Borken, Germany
Investigational site, Trauerberg 27-28
Brandenburg/Havel, Germany
Investigational site, Wetzlarer Straße 22
Butzbach, Germany
Investigational site, Hermann-Hesse-Platz 3
Calw, Germany
Investigational site, Dortmunder Straße
Castrop-Rauxl, Germany
Investigational site, Hainstraße 112
Chemnitz, Germany
Investigational site, Graseggerstraße 105
Cologne, Germany
Investigational site, Venloer Straße 247
Cologne, Germany
Investigational site, Bahnhofstraße 64
Cottbus, Germany
Investigational site, Vetschauer Straße 11a
Cottbus, Germany
Investigational site, Frankfurter Straße 3
Darmstadt, Germany
Investigational site, Rheinstraße 44-46
Darmstadt, Germany
Investigational site, Lagesche Straße 19
Detmold, Germany
Investigational site, Jahnstraße 1
Dingolfing, Germany
Investigational site, Karlsbader Straße 7
Dinkelsbühl, Germany
Investigational site, Recklinghäuser Straße 14
Dorsten, Germany
Investigational site, Rheinlanddamm 10
Dortmund, Germany
Investigational site, Lukasstraße 3
Dresden, Germany
Investigational site, Rehefelder Straße 12
Dresden, Germany
Investigational site, Mühlhäuser Straße 94, Haus F
Eisenach, Germany
Investigational site, Winkelgasse 1
Ellefeld, Germany
Investigational site, Königstraße 12-14
Elmshorn, Germany
Investigational site, Märkischestraße 30
Engelskirchen, Germany
Investigational site, Franz-Busbach-Straße 8
Erftstadt, Germany
Investigational site, Neuwerkstraße 2
Erfurt, Germany
Investigational site, Ruhrallee 81
Essen, Germany
Investigational site, Viktoriastraße 5
Euskirchen, Germany
Investigational site, Im Prüfling 23
Frankfurt, Germany
Investigational site, Hochstraße 43
Frankfurt am Main, Germany
Investigational site, Pfingsweidstraße 4
Frankfurt am Main, Germany
Investigational site, Stresemannallee 3
Frankfurt am Main, Germany
Investigational site, Habsburgerstraße 105
Freiburg im Breisgau, Germany
Investigational site, Schnetzenhauser Straße 5
Friedrichshafen, Germany
Investigational site, Moststraße 19
Fürth, Germany
Investigational site, Gartenstraße 29
Gardelegen, Germany
Investigational site, Hauptstraße 60-64
Garmisch-Partenkirchen, Germany
Investigational site, Am Markt 3
Gehrden, Germany
Investigational site, In der Heide 19
Gelsenkirchen, Germany
Investigational site, Von-der-Recke-Straße 14
Gelsenkirchen, Germany
Investigational site, Pollinger Straße 23
Gilching, Germany
Investigational site, Von-Werth-Straße 5
Grevenbroich, Germany
Investigational site, Avenwedder Straße 50
Gütersloh, Germany
Investigational site, Hachelweg 19
Hachelweg 19, Germany
Investigational site, Fürstin-Eugenie-Straße 7
Hachingen, Germany
Investigational site, Buscheystraße 15a
Hagen, 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
Hamburg, Germany
Investigational site, Sudetenweg 6
Hamm, Germany
Investigational site, Staufenbergstraße 31
Heilbronn, Germany
Investigational site, Frankfurter Straße 100a
Hennef (Sieg), Germany
Investigational site, Am Ruschenhof 24
Herne, Germany
Investigational site, Wiescherstraße 20
Herne, Germany
Investigational site, Seestraße 43
Herrsching am Ammersee, Germany
Investigational site, Waisenhausstraße 2
Iserlohn, Germany
Investigational site, J.-Lange-straße 20
Jerichow, Germany
Investigational site, Prinzenallee 10
Jever, Germany
Investigational site, Hans-Sachs-Straße 1
Karlsruhe, Germany
Investigational site, Am Tiefen Weg 2
Karlstadt am Main, Germany
Investigational site, Opernstraße 9
Kassel, Germany
Investigational site, Feldstraße 5-7
Kiel, Germany
Investigational site, Moltkestraße 9
Kitzingen, Germany
Investigational site, Herzog-Adolph-Straße 13
Königstein, Germany
Investigational site, Schalaunische Straße 6-7
Köthen, Germany
Investigational site, Dreifaltigkeitsplatz 177
Landshut, Germany
Investigational site, Röntgenstraße 6-8
Langen, Germany
Investigational site, Funkenburgstraße 19
Leipzig, Germany
Investigational site, Johannisplatz 1
Leipzig, Germany
Investigational site, Markt 3
Leisnig, Germany
Investigational site, Am Gesundheitspark 11
Leverkusen, Germany
Investigational site, Yorckstraße 1
Ludwigshafen, Germany
Investigational site, Kronsforder Allee 19
Lübeck, Germany
Investigational site, Kronsforder Allee 69
Lübeck, Germany
Investigational site, Bismarckplatz 1
Mannheim, Germany
Investigational site, Stiftsweg 17
Mechernich, 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
München, Germany
Investigational site, Unterer Markt 26-27
Neumarkt, Germany
Investigational site, Hofgründchen 13
Neuwied, Germany
Investigational site, Am Stadtpark 2
Nuremberg, Germany
Investigational site, Glogauer Straße 42
Nuremberg, Germany
Investigational site, Weiltinger Straße 11
Nuremberg, Germany
Investigational site, Hauptstraße 36
Oldenburg, Germany
Investigational site, Neue Donnerschweer Straße 30
Oldenburg, Germany
Investigational site, Ofener Straße 30
Oldenburg, Germany
Investigational site, Bramscher Straße 242
Osnabrück, Germany
Investigational site, Le-Mans-Wall 5
Paderborn, Germany
Investigational site, Westendstraße 38
Paderborn, Germany
Investigational site, Haptkanal rechts 75
Papenburg, Germany
Investigational site, Neundorfer Straße 14
Plauen, Germany
Investigational site, Allee nach Sanccouci 7
Potsdam, Germany
Investigational site, Großbeerenstraße 301
Potsdam, Germany
Investigational site, R.-Breitscheid-Straße 56
Potsdam, Germany
Investigational site, Kaiserstraße 166
Radevormwald, Germany
Investigational site, Neue Straße 34
Reinsdorf, Germany
Investigational site, Keramikerstraße 61
Rheinbach, Germany
Investigational site, St.-Petersburger-straße 18c
Rostock, Germany
Investigational site, Tegernseerstraße 100
Rottach-Weissach, Germany
Investigational site, Marktplatz 23
Rottenburg, Germany
Investigational site, Waldhausstraße 13
Schmalkalden, Germany
Investigational site, Krankenhausstraße 20
Schwalmstadt, Germany
Investigational site, Virchowstraße 10c
Singen, Germany
Investigational site, Wallstraße 38
Stade, Germany
Investigational site, Am Wallgraben 99
Stuttgart, Germany
Investigational site, Röhre 1
Sundern, Germany
Investigational site, Straße des Friedens 34c
Teuchern, Germany
Investigational site, Hambrocker Straße 53
Uelzen, Germany
Investigational site, Andreaestraße 16/1
Vahingen, Germany
Investigational site, Hochstraße 20
Waltrop, Germany
Investigational site, Kletzstraße 13B
Waren, Germany
Investigational site, Fischergasse 16
Weilheim, Germany
Investigational site, Julius-Leber-Strasße 8
Wesel, Germany
Investigational site, Westring 14
Wesseling, Germany
Investigational site, Forsthausstraße 1e
Wetzlar, Germany
Investigational site, Berliner Straße 8
Wittenberg, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2012
First Posted
January 25, 2012
Study Start
February 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
October 1, 2015
Record last verified: 2015-09