Mesalazine (PENTASA®) in Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Other: Mesalazine
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 506
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Mesalazine Mesalazine -
- 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, Marienstraße 6
🇩🇪Amberg, Germany
Investigational site, Adam-Ries-Straße 57c
🇩🇪Annaberg-Buchholz, Germany
Investigational site, Goethestraße 5
🇩🇪Ansbach, Germany
Investigational site, Goethestraße 15g
🇩🇪Bad Neustadt, Germany
Investigational site, Bahnhofstraße 18
🇩🇪Berlin, Germany
Investigational site, Recklinghäuser Straße 14
🇩🇪Dorsten, Germany
Investigational site, Viktoriastraße 5
🇩🇪Euskirchen, Germany
Investigational site, Im Prüfling 23
🇩🇪Frankfurt, Germany
Investigational site, Buscheystraße 15a
🇩🇪Hagen, Germany
Investigational site, Unterer Markt 26-27
🇩🇪Neumarkt, Germany
Investigational site, Blankenburger Chaussee 86
🇩🇪Berlin, Germany
Investigational site, Wettinerstraße 22
🇩🇪Altenburg, Germany
Investigational site, Prinzregentenstraße 8
🇩🇪Augsburg, Germany
Investigational site, Elisenstraße 32
🇩🇪Aschaffenburg, Germany
Investigational site, Koblenzer Straße 37
🇩🇪Bad Godesberg, Germany
Investigational site, Töpferstraße 17
🇩🇪Bautzen, Germany
Investigational site, Bundesallee 104-105
🇩🇪Berlin, Germany
Investigational site, Ehrenfelsstraße 47
🇩🇪Berlin, Germany
Investigational site, Hohenzollerndamm 47a
🇩🇪Berlin, Germany
Investigational site, Etkar-Andre-Straße 8
🇩🇪Berlin, Germany
Investigational site, Treskowallee 99
🇩🇪Berlin, Germany
Investigational site, Kurfürstendamm 42
🇩🇪Berlin, Germany
Investigational site, Innsbrucker Straße 58
🇩🇪Berlin, Germany
Investigational site, Klosterstraße 34
🇩🇪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, Kasernenstraße 22-24
🇩🇪Bonn, Germany
Investigational site, Hauptstraße 88
🇩🇪Bielefeld, Germany
Investigational site, Trauerberg 27-28
🇩🇪Brandenburg/Havel, Germany
Investigational site, Münsterstraße 18
🇩🇪Bonn, Germany
Investigational site, Vetschauer Straße 11a
🇩🇪Cottbus, Germany
Investigational site, Hauptstraße 9
🇩🇪Bietigheim-Bissingen, Germany
Investigational site, Propst-Sievert-Weg 9
🇩🇪Borken, Germany
Investigational site, Wetzlarer Straße 22
🇩🇪Butzbach, Germany
Investigational site, Dortmunder Straße
🇩🇪Castrop-Rauxl, Germany
Investigational site, Hermann-Hesse-Platz 3
🇩🇪Calw, Germany
Investigational site, Hainstraße 112
🇩🇪Chemnitz, Germany
Investigational site, Bahnhofstraße 64
🇩🇪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, Lukasstraße 3
🇩🇪Dresden, Germany
Investigational site, Karlsbader Straße 7
🇩🇪Dinkelsbühl, Germany
Investigational site, Rheinlanddamm 10
🇩🇪Dortmund, 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, Hochstraße 43
🇩🇪Frankfurt Main, Germany
Investigational site, Ruhrallee 81
🇩🇪Essen, Germany
Investigational site, Stresemannallee 3
🇩🇪Frankfurt Main, Germany
Investigational site, Hauptstraße 60-64
🇩🇪Garmisch-Partenkirchen, Germany
Investigational site, Pfingsweidstraße 4
🇩🇪Frankfurt Main, Germany
Investigational site, Moststraße 19
🇩🇪Fürth, Germany
Investigational site, Habsburgerstraße 105
🇩🇪Freiburg, Germany
Investigational site, Gartenstraße 29
🇩🇪Gardelegen, Germany
Investigational site, Schnetzenhauser Straße 5
🇩🇪Friedrichshafen, 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, Hachelweg 19
🇩🇪Hachelweg 19, Germany
Investigational site, Avenwedder Straße 50
🇩🇪Gütersloh, Germany
Investigational site, Fürstin-Eugenie-Straße 7
🇩🇪Hachingen, Germany
Investigational site, Eppendorfer Landstraße 42
🇩🇪Hamburg, Germany
Investigational site, Eppendorfer Baum 35-37
🇩🇪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, Staufenbergstraße 31
🇩🇪Heilbronn, Germany
Investigational site, Sudetenweg 6
🇩🇪Hamm, Germany
Investigational site, Wiescherstraße 20
🇩🇪Herne, Germany
Investigational site, Frankfurter Straße 100a
🇩🇪Hennef, Germany
Investigational site, Am Ruschenhof 24
🇩🇪Herne, Germany
Investigational site, Waisenhausstraße 2
🇩🇪Iserlohn, Germany
Investigational site, Seestraße 43
🇩🇪Herrsching, Germany
Investigational site, J.-Lange-straße 20
🇩🇪Jerichow, Germany
Investigational site, Am Tiefen Weg 2
🇩🇪Karlstadt, Germany
Investigational site, Prinzenallee 10
🇩🇪Jever, Germany
Investigational site, Opernstraße 9
🇩🇪Kassel, Germany
Investigational site, Hans-Sachs-Straße 1
🇩🇪Karlsruhe, Germany
Investigational site, Feldstraße 5-7
🇩🇪Kiel, Germany
Investigational site, Moltkestraße 9
🇩🇪Kitzingen, Germany
Investigational site, Herzog-Adolph-Straße 13
🇩🇪Königstein, Germany
Investigational site, Venloer Straße 247
🇩🇪Köln, Germany
Investigational site, Graseggerstraße 105
🇩🇪Köln, Germany
Investigational site, Berliner Straße 8
🇩🇪Lutherstadt Wittenberg, Germany
Investigational site, Schalaunische Straße 6-7
🇩🇪Köthen, Germany
Investigational site, Röntgenstraße 6-8
🇩🇪Langen, Germany
Investigational site, Dreifaltigkeitsplatz 177
🇩🇪Landshut, Germany
Investigational site, Markt 3
🇩🇪Leisnig, Germany
Investigational site, Yorckstraße 1
🇩🇪Ludwigshafen, Germany
Investigational site, Funkenburgstraße 19
🇩🇪Leipzig, Germany
Investigational site, Johannisplatz 1
🇩🇪Leipzig, Germany
Investigational site, Am Gesundheitspark 11
🇩🇪Leverkusen, Germany
Investigational site, Kronsforder Allee 19
🇩🇪Lübeck, Germany
Investigational site, Kronsforder Allee 69
🇩🇪Lübeck, Germany
Investigational site, Am Harras 2
🇩🇪München, Germany
Investigational site, Bismarckplatz 1
🇩🇪Mannheim, Germany
Investigational site, Stiftsweg 17
🇩🇪Mechernich, Germany
Investigational site, Kaulbachstraße 61
🇩🇪München, Germany
Investigational site, Schönfeldstraße 16
🇩🇪München, Germany
Investigational site, Irisstraße 23
🇩🇪München, Germany
Investigational site, Maximilianstraße 16
🇩🇪München, Germany
Investigational site, Weiltinger Straße 11
🇩🇪Nürnberg, Germany
Investigational site, Hofgründchen 13
🇩🇪Neuwied, Germany
Investigational site, Am Stadtpark 2
🇩🇪Nürnberg, Germany
Investigational site, Glogauer Straße 42
🇩🇪Nürnberg, Germany
Investigational site, Hauptstraße 36
🇩🇪Oldenburg, Germany
Investigational site, Neue Donnerschweer Straße 30
🇩🇪Oldenburg, Germany
Investigational site, Bramscher Straße 242
🇩🇪Osnabrück, Germany
Investigational site, Le-Mans-Wall 5
🇩🇪Paderborn, Germany
Investigational site, Ofener Straße 30
🇩🇪Oldenburg, Germany
Investigational site, Westendstraße 38
🇩🇪Paderborn, Germany
Investigational site, Großbeerenstraße 301
🇩🇪Potsdam, 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, Kaiserstraße 166
🇩🇪Radevormwald, Germany
Investigational site, R.-Breitscheid-Straße 56
🇩🇪Potsdam, Germany
Investigational site, St.-Petersburger-straße 18c
🇩🇪Rostock, Germany
Investigational site, Keramikerstraße 61
🇩🇪Rheinbach, Germany
Investigational site, Neue Straße 34
🇩🇪Reinsdorf, Germany
Investigational site, Tegernseerstraße 100
🇩🇪Rottach-Weissach, Germany
Investigational site, Röhre 1
🇩🇪Sundern, Germany
Investigational site, Marktplatz 23
🇩🇪Rottenburg, Germany
Investigational site, Krankenhausstraße 20
🇩🇪Schwalmstadt, Germany
Investigational site, Am Wallgraben 99
🇩🇪Stuttgart, Germany
Investigational site, Waldhausstraße 13
🇩🇪Schmalkalden, Germany
Investigational site, Virchowstraße 10c
🇩🇪Singen, Germany
Investigational site, Wallstraße 38
🇩🇪Stade, Germany
Investigational site, Straße des Friedens 34c
🇩🇪Teuchern, Germany
Investigational site, Andreaestraße 16/1
🇩🇪Vahingen, Germany
Investigational site, Hambrocker Straße 53
🇩🇪Uelzen, Germany
Investigational site, Kletzstraße 13B
🇩🇪Waren, Germany
Investigational site, Hochstraße 20
🇩🇪Waltrop, 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