Mesalazine (PENTASA®) in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— MUKOSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517607
• Other study ID #: 000027
• Status: Completed
• Phase: N/A
• First received: January 20, 2012
• Last updated: September 30, 2015
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Mesalazine
Patient's treated with oral Mesalazine

Locations

Country	Name	City	State
Germany	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	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, 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 Main
Germany	Investigational site, Pfingsweidstraße 4	Frankfurt Main
Germany	Investigational site, Stresemannallee 3	Frankfurt Main
Germany	Investigational site, Habsburgerstraße 105	Freiburg
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, Schäferkampsallee 56-58	Hamburg
Germany	Investigational site, Schlossstrasse 44	Hamburg
Germany	Investigational site, Sudetenweg 6	Hamm
Germany	Investigational site, Staufenbergstraße 31	Heilbronn
Germany	Investigational site, Frankfurter Straße 100a	Hennef
Germany	Investigational site, Am Ruschenhof 24	Herne
Germany	Investigational site, Wiescherstraße 20	Herne
Germany	Investigational site, Seestraße 43	Herrsching
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
Germany	Investigational site, Opernstraße 9	Kassel
Germany	Investigational site, Feldstraße 5-7	Kiel
Germany	Investigational site, Moltkestraße 9	Kitzingen
Germany	Investigational site, Graseggerstraße 105	Köln
Germany	Investigational site, Venloer Straße 247	Köln
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, Kronsforder Allee 19	Lübeck
Germany	Investigational site, Kronsforder Allee 69	Lübeck
Germany	Investigational site, Yorckstraße 1	Ludwigshafen
Germany	Investigational site, Berliner Straße 8	Lutherstadt Wittenberg
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	Nürnberg
Germany	Investigational site, Glogauer Straße 42	Nürnberg
Germany	Investigational site, Weiltinger Straße 11	Nürnberg
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

Sponsors (2)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals	Ferring Arzneimittel GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient compliance: Measured by patient response to a questionnaire		Month 0 - Month 12	No
Secondary	Patient's level of information: Measured by patient response to a questionnaire		Month 0 - Month 12	No
Secondary	Patient's preference for the oral pharmaceutical form: Measured by patient response to a questionnaire		Month 0 - Month 12	No
Secondary	Reasons for the therapeutic decision of the physician: Measured by physician responses		Month 0	No
Secondary	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)	Month 0- Month 12	No
Secondary	Ulcerative Colitis Disease Activity Index (UCDAI)	UCDAI = Blood in stool, stool frequency, overall evaluation of the physician, endoscopic evaluation (optional)	Month 0 - Month 12	No
Secondary	Adverse drug reactions: measured by number of patients and event severity		Month 0 - Month 12	Yes