Clinical trial NCT01517607: Mesalazine (PENTASA®) in Ulcerative Colitis
Official title: Mesalazine (PENTASA®) in Ulcerative Colitis: Correlation of the Information Level With Patient's Compliance in Everyday Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring Arzneimittel GmbH
First posted: 2012-01-25
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care facilities

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient compliance: Measured by patient response to a questionnaire
timeFrame: Month 0 - Month 12
Secondary outcomes:
measure: Patient's level of information: Measured by patient response to a questionnaire
timeFrame: Month 0 - Month 12
measure: Patient's preference for the oral pharmaceutical form: Measured by patient response to a questionnaire
timeFrame: Month 0 - Month 12
measure: Reasons for the therapeutic decision of the physician: Measured by physician responses
timeFrame: Month 0
measure: Laboratory parameters of predefined blood measurements
timeFrame: Month 0- Month 12
measure: Ulcerative Colitis Disease Activity Index (UCDAI)
timeFrame: Month 0 - Month 12
measure: Adverse drug reactions: measured by number of patients and event severity
timeFrame: Month 0 - Month 12
Other outcomes:
Locations:
city: Altenburg
country: Germany
facility: Investigational site, Wettinerstraße 22
city: Amberg
country: Germany
facility: Investigational site, Marienstraße 6
city: Annaberg-Buchholz
country: Germany
facility: Investigational site, Adam-Ries-Straße 57c
city: Ansbach
country: Germany
facility: Investigational site, Goethestraße 5
city: Aschaffenburg
country: Germany
facility: Investigational site, Elisenstraße 32
city: Augsburg
country: Germany
facility: Investigational site, Prinzregentenstraße 8
city: Bad Godesberg
country: Germany
facility: Investigational site, Koblenzer Straße 37
city: Bad Neustadt
country: Germany
facility: Investigational site, Goethestraße 15g
city: Bautzen
country: Germany
facility: Investigational site, Töpferstraße 17
city: Berlin
country: Germany
facility: Investigational site, Bahnhofstraße 18
city: Berlin
country: Germany
facility: Investigational site, Blankenburger Chaussee 86
city: Berlin
country: Germany
facility: Investigational site, Bundesallee 104-105
city: Berlin
country: Germany
facility: Investigational site, Ehrenfelsstraße 47
city: Berlin
country: Germany
facility: Investigational site, Etkar-Andre-Straße 8
city: Berlin
country: Germany
facility: Investigational site, Hohenzollerndamm 47a
city: Berlin
country: Germany
facility: Investigational site, Innsbrucker Straße 58
city: Berlin
country: Germany
facility: Investigational site, Klosterstraße 34
city: Berlin
country: Germany
facility: Investigational site, Kurfürstendamm 42
city: Berlin
country: Germany
facility: Investigational site, Mohrenstraße 6
city: Berlin
country: Germany
facility: Investigational site, Myslowitzer Straße 49
city: Berlin
country: Germany
facility: Investigational site, Schönhauser Allee 118
city: Berlin
country: Germany
facility: Investigational site, Schönhauser Allee 129
city: Berlin
country: Germany
facility: Investigational site, Schönstraße 90
city: Berlin
country: Germany
facility: Investigational site, Treskowallee 99
city: Bielefeld
country: Germany
facility: Investigational site, Hauptstraße 88
city: Bietigheim-Bissingen
country: Germany
facility: Investigational site, Hauptstraße 9
city: Bonn
country: Germany
facility: Investigational site, Kasernenstraße 22-24
city: Bonn
country: Germany
facility: Investigational site, Münsterstraße 18
city: Borken
country: Germany
facility: Investigational site, Propst-Sievert-Weg 9
city: Brandenburg/Havel
country: Germany
facility: Investigational site, Trauerberg 27-28
city: Butzbach
country: Germany
facility: Investigational site, Wetzlarer Straße 22
city: Calw
country: Germany
facility: Investigational site, Hermann-Hesse-Platz 3
city: Castrop-Rauxl
country: Germany
facility: Investigational site, Dortmunder Straße
city: Chemnitz
country: Germany
facility: Investigational site, Hainstraße 112
city: Cottbus
country: Germany
facility: Investigational site, Bahnhofstraße 64
city: Cottbus
country: Germany
facility: Investigational site, Vetschauer Straße 11a
city: Darmstadt
country: Germany
facility: Investigational site, Frankfurter Straße 3
city: Darmstadt
country: Germany
facility: Investigational site, Rheinstraße 44-46
city: Detmold
country: Germany
facility: Investigational site, Lagesche Straße 19
city: Dingolfing
country: Germany
facility: Investigational site, Jahnstraße 1
city: Dinkelsbühl
country: Germany
facility: Investigational site, Karlsbader Straße 7
city: Dorsten
country: Germany
facility: Investigational site, Recklinghäuser Straße 14
city: Dortmund
country: Germany
facility: Investigational site, Rheinlanddamm 10
city: Dresden
country: Germany
facility: Investigational site, Lukasstraße 3
city: Dresden
country: Germany
facility: Investigational site, Rehefelder Straße 12
city: Eisenach
country: Germany
facility: Investigational site, Mühlhäuser Straße 94, Haus F
city: Ellefeld
country: Germany
facility: Investigational site, Winkelgasse 1
city: Elmshorn
country: Germany
facility: Investigational site, Königstraße 12-14
city: Engelskirchen
country: Germany
facility: Investigational site, Märkischestraße 30
city: Erftstadt
country: Germany
facility: Investigational site, Franz-Busbach-Straße 8
city: Erfurt
country: Germany
facility: Investigational site, Neuwerkstraße 2
city: Essen
country: Germany
facility: Investigational site, Ruhrallee 81
city: Euskirchen
country: Germany
facility: Investigational site, Viktoriastraße 5
city: Frankfurt Main
country: Germany
facility: Investigational site, Hochstraße 43
city: Frankfurt Main
country: Germany
facility: Investigational site, Pfingsweidstraße 4
city: Frankfurt Main
country: Germany
facility: Investigational site, Stresemannallee 3
city: Frankfurt
country: Germany
facility: Investigational site, Im Prüfling 23
city: Freiburg
country: Germany
facility: Investigational site, Habsburgerstraße 105
city: Friedrichshafen
country: Germany
facility: Investigational site, Schnetzenhauser Straße 5
city: Fürth
country: Germany
facility: Investigational site, Moststraße 19
city: Gardelegen
country: Germany
facility: Investigational site, Gartenstraße 29
city: Garmisch-Partenkirchen
country: Germany
facility: Investigational site, Hauptstraße 60-64
city: Gehrden
country: Germany
facility: Investigational site, Am Markt 3
city: Gelsenkirchen
country: Germany
facility: Investigational site, In der Heide 19
city: Gelsenkirchen
country: Germany
facility: Investigational site, Von-der-Recke-Straße 14
city: Gilching
country: Germany
facility: Investigational site, Pollinger Straße 23
city: Grevenbroich
country: Germany
facility: Investigational site, Von-Werth-Straße 5
city: Gütersloh
country: Germany
facility: Investigational site, Avenwedder Straße 50
city: Hachelweg 19
country: Germany
facility: Investigational site, Hachelweg 19
city: Hachingen
country: Germany
facility: Investigational site, Fürstin-Eugenie-Straße 7
city: Hagen
country: Germany
facility: Investigational site, Buscheystraße 15a
city: Hamburg
country: Germany
facility: Investigational site, Eppendorfer Baum 35-37
city: Hamburg
country: Germany
facility: Investigational site, Eppendorfer Landstraße 42
city: Hamburg
country: Germany
facility: Investigational site, Fontenay 1d
city: Hamburg
country: Germany
facility: Investigational site, Harksheider Straße 3
city: Hamburg
country: Germany
facility: Investigational site, Schlossstrasse 44
city: Hamburg
country: Germany
facility: Investigational site, Schäferkampsallee 56-58
city: Hamm
country: Germany
facility: Investigational site, Sudetenweg 6
city: Heilbronn
country: Germany
facility: Investigational site, Staufenbergstraße 31
city: Hennef
country: Germany
facility: Investigational site, Frankfurter Straße 100a
city: Herne
country: Germany
facility: Investigational site, Am Ruschenhof 24
city: Herne
country: Germany
facility: Investigational site, Wiescherstraße 20
city: Herrsching
country: Germany
facility: Investigational site, Seestraße 43
city: Iserlohn
country: Germany
facility: Investigational site, Waisenhausstraße 2
city: Jerichow
country: Germany
facility: Investigational site, J.-Lange-straße 20
city: Jever
country: Germany
facility: Investigational site, Prinzenallee 10
city: Karlsruhe
country: Germany
facility: Investigational site, Hans-Sachs-Straße 1
city: Karlstadt
country: Germany
facility: Investigational site, Am Tiefen Weg 2
city: Kassel
country: Germany
facility: Investigational site, Opernstraße 9
city: Kiel
country: Germany
facility: Investigational site, Feldstraße 5-7
city: Kitzingen
country: Germany
facility: Investigational site, Moltkestraße 9
city: Köln
country: Germany
facility: Investigational site, Graseggerstraße 105
city: Köln
country: Germany
facility: Investigational site, Venloer Straße 247
city: Königstein
country: Germany
facility: Investigational site, Herzog-Adolph-Straße 13
city: Köthen
country: Germany
facility: Investigational site, Schalaunische Straße 6-7
city: Landshut
country: Germany
facility: Investigational site, Dreifaltigkeitsplatz 177
city: Langen
country: Germany
facility: Investigational site, Röntgenstraße 6-8
city: Leipzig
country: Germany
facility: Investigational site, Funkenburgstraße 19
city: Leipzig
country: Germany
facility: Investigational site, Johannisplatz 1
city: Leisnig
country: Germany
facility: Investigational site, Markt 3
city: Leverkusen
country: Germany
facility: Investigational site, Am Gesundheitspark 11
city: Ludwigshafen
country: Germany
facility: Investigational site, Yorckstraße 1
city: Lutherstadt Wittenberg
country: Germany
facility: Investigational site, Berliner Straße 8
city: Lübeck
country: Germany
facility: Investigational site, Kronsforder Allee 19
city: Lübeck
country: Germany
facility: Investigational site, Kronsforder Allee 69
city: Mannheim
country: Germany
facility: Investigational site, Bismarckplatz 1
city: Mechernich
country: Germany
facility: Investigational site, Stiftsweg 17
city: München
country: Germany
facility: Investigational site, Am Harras 2
city: München
country: Germany
facility: Investigational site, Irisstraße 23
city: München
country: Germany
facility: Investigational site, Kaulbachstraße 61
city: München
country: Germany
facility: Investigational site, Maximilianstraße 16
city: München
country: Germany
facility: Investigational site, Schönfeldstraße 16
city: Neumarkt
country: Germany
facility: Investigational site, Unterer Markt 26-27
city: Neuwied
country: Germany
facility: Investigational site, Hofgründchen 13
city: Nürnberg
country: Germany
facility: Investigational site, Am Stadtpark 2
city: Nürnberg
country: Germany
facility: Investigational site, Glogauer Straße 42
city: Nürnberg
country: Germany
facility: Investigational site, Weiltinger Straße 11
city: Oldenburg
country: Germany
facility: Investigational site, Hauptstraße 36
city: Oldenburg
country: Germany
facility: Investigational site, Neue Donnerschweer Straße 30
city: Oldenburg
country: Germany
facility: Investigational site, Ofener Straße 30
city: Osnabrück
country: Germany
facility: Investigational site, Bramscher Straße 242
city: Paderborn
country: Germany
facility: Investigational site, Le-Mans-Wall 5
city: Paderborn
country: Germany
facility: Investigational site, Westendstraße 38
city: Papenburg
country: Germany
facility: Investigational site, Haptkanal rechts 75
city: Plauen
country: Germany
facility: Investigational site, Neundorfer Straße 14
city: Potsdam
country: Germany
facility: Investigational site, Allee nach Sanccouci 7
city: Potsdam
country: Germany
facility: Investigational site, Großbeerenstraße 301
city: Potsdam
country: Germany
facility: Investigational site, R.-Breitscheid-Straße 56
city: Radevormwald
country: Germany
facility: Investigational site, Kaiserstraße 166
city: Reinsdorf
country: Germany
facility: Investigational site, Neue Straße 34
city: Rheinbach
country: Germany
facility: Investigational site, Keramikerstraße 61
city: Rostock
country: Germany
facility: Investigational site, St.-Petersburger-straße 18c
city: Rottach-Weissach
country: Germany
facility: Investigational site, Tegernseerstraße 100
city: Rottenburg
country: Germany
facility: Investigational site, Marktplatz 23
city: Schmalkalden
country: Germany
facility: Investigational site, Waldhausstraße 13
city: Schwalmstadt
country: Germany
facility: Investigational site, Krankenhausstraße 20
city: Singen
country: Germany
facility: Investigational site, Virchowstraße 10c
city: Stade
country: Germany
facility: Investigational site, Wallstraße 38
city: Stuttgart
country: Germany
facility: Investigational site, Am Wallgraben 99
city: Sundern
country: Germany
facility: Investigational site, Röhre 1
city: Teuchern
country: Germany
facility: Investigational site, Straße des Friedens 34c
city: Uelzen
country: Germany
facility: Investigational site, Hambrocker Straße 53
city: Vahingen
country: Germany
facility: Investigational site, Andreaestraße 16/1
city: Waltrop
country: Germany
facility: Investigational site, Hochstraße 20
city: Waren
country: Germany
facility: Investigational site, Kletzstraße 13B
city: Weilheim
country: Germany
facility: Investigational site, Fischergasse 16
city: Wesel
country: Germany
facility: Investigational site, Julius-Leber-Strasße 8
city: Wesseling
country: Germany
facility: Investigational site, Westring 14
city: Wetzlar
country: Germany
facility: Investigational site, Forsthausstraße 1e
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: