Ulcerative Colitis Clinical Trial
— CAREOfficial title:
Acute and Remission Therapy of Ulcerative Colitis With Oral Mesalazine
The aim of the non-interventional study is to document the daily doses in acute and remission therapy, the frequence of doses (1, 2, 3 or 4 times daily), when rectal dosage forms are added and, when and how long steroids are given.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | July 2008 |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - therapeutic need according to SPC - written informed consent Exclusion Criteria: - contraindications according to SPC |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Investigational , Karlsplatz 18 | Aalen | |
| Germany | Investigational Site, Goethestraße 5 | Ansbach | |
| Germany | Investigational Site, Elisenstraße 32 | Aschaffenburg | |
| Germany | Investigational Site, Haingasse 22 | Bad Homburg | |
| Germany | Investigational Site, Blankenburger Chaussee 86 | Berlin | |
| Germany | Investigational Site, Etkar-André-Straße 8 | Berlin | |
| Germany | Investigational Site, Karl-Marx-Straße 46 | Berlin | |
| Germany | Investigational Site, Martin-Luther-Straße 134 | Berlin | |
| Germany | Investigational Site, Mohrenstraße 6 | Berlin | |
| Germany | Investigational Site, Myslowitzer Straße 49 | Berlin | |
| Germany | Investigational Site, Plügerstraße 75 | Berlin | |
| Germany | Investigational Site, Schönhauser Allee 129 | Berlin | |
| Germany | Investigational Site, Hauptstraße 13 - 15 | Birkenfeld | |
| Germany | Investigational Site, Kurt-Schumacher-Platz 4 | Bochum | |
| Germany | Investigational Site, Am Burgweiher 54 | Bonn | |
| Germany | Investigational Site, Kasernenstraße 22 - 24 | Bonn | |
| Germany | Investigational Site, Münsterstraße 18 | Bonn | |
| Germany | Investigational Site, Trauerberg 27/28 | Brandenburg | |
| Germany | Investigational Site, Hermann-Hesse-Platz 3 | Calw | |
| Germany | Investigational Site, Moritzstraße 19 | Chemnitz | |
| Germany | Investigational Site, Osterstraße 44 | Cloppenburg | |
| Germany | Investigational Site, Leipziger Straße 45 b | Cottbus | |
| Germany | Investigational Site, Münchner Straße 64 | Dachau | |
| Germany | Investigational Site, Schäfergraben 5 H | Delitzsch | |
| Germany | Investigational Site, Hans-Böckler-Straße 20 | Dinslaken | |
| Germany | Investigational Site, Schadowstraße 42 | Düsseldorf | |
| Germany | Investigational Site, Simrockstraße 56 | Düsseldorf | |
| Germany | Investigational Site, Ludwig-Sandberg-Straße 4 | Eberswalde | |
| Germany | Investigational Site, Neuzeller Landweg 1 | Eisenhüttenstadt | |
| Germany | Investigational Site, Mühlendamm 23 | Elmshorn | |
| Germany | Investigational Site, Franz-Busbach-Str. 8 | Erftstadt | |
| Germany | Investigational Site, Neuwerkstraße 2 | Erfurt | |
| Germany | Investigational Site, Lehmanns Brink 5 | Essen | |
| Germany | Investigational Site, Steeler Straße 204 | Essen | |
| Germany | Investigational Site, Viktoriastraße 5 | Euskirchen | |
| Germany | Investigational Site, Sorauer Straße 56 | Forst | |
| Germany | Investigational Site, Im Prüfling 23 | Frankfurt Main | |
| Germany | Investigational Site, Pfingstweidestraße 4 | Frankfurt Main | |
| Germany | Investigational Site, Finkenstraße 31 | Freising | |
| Germany | Investigational Site, Bahnhofstraße 16 | Fulda | |
| Germany | Investigational Site, Bahnhofplatz 11 | Fürth | |
| Germany | Investigational Site, Straßburger Weg 4 | Gelsenkirchen | |
| Germany | Investigational Site, Hinter der Mauer 105 | Goch | |
| Germany | Investigational Site, Waldweg 1 | Göttingen | |
| Germany | Investigational Site, Buscheystraße 15 a | Hagen | |
| Germany | Investigational Site, Drosselstraße 6 A | Hamburg | |
| Germany | Investigational Site, Eppendorfer Baum 35-37 | Hamburg | |
| Germany | Investigational Site, Fontenay 1 d | Hamburg | |
| Germany | Investigational Site, Propst-Paulsen-Straße 2 | Hamburg | |
| Germany | Investigational Site, Schweriner Straße 1 | Hamburg | |
| Germany | Investigational Site, Rathausplatz 4 | Haßloch | |
| Germany | Investigational Site, Kurfürstenanlage 34 | Heidelberg | |
| Germany | Investigational Site, Luisenstraße 18 a | Hettstedt | |
| Germany | Investigational Site, Hohensachsener Str. 2 | Hirschberg | |
| Germany | Investigational Site, Robert-Koch-Straße 2 | Hofheim | |
| Germany | Investigational Site, M.-Grollmuß-Straße 10 | Hoyerswerda | |
| Germany | Investigational Site, J.-Lange-Straße 20, Haus 7 | Jerichow | |
| Germany | Investigational Site, Goethestraße 11 | Kiel | |
| Germany | Investigational Site, Poggendörper Weg 3-9 | Kiel | |
| Germany | Investigational Site, Markenbildchenweg 30 | Koblenz | |
| Germany | Investigational Site, Herzog-Adolph-Straße 13 | Konigstein im Taunus | |
| Germany | Investigational Site, Schalaunische Strape 6/7 | Köthen | |
| Germany | Investigational Site, Friesener Straße 41 | Kronach | |
| Germany | Investigational Site, Auf dem Wall 6 | Lindau | |
| Germany | Investigational Site, Königstraße 81 | Lübeck | |
| Germany | Investigational Site, Potsdamer Straße 120A | Ludwigsfelde | |
| Germany | Investigational Site, Rheingönheimer Str. 121 | Ludwigshafen | |
| Germany | Investigational Site, Weißdornhag 2 | Ludwigshafen | |
| Germany | Investigational Site, Pfeifferstraße 10 | Magdeburg | |
| Germany | Investigational Site, Weißliliengasse 31 | Mainz | |
| Germany | Investigational Site, Auf dem Sand 76a | Mannheim | |
| Germany | Investigational Site, Zur Stadthalle 2 | Merzig | |
| Germany | Investigational Site, Zum Schotzberg 1 a | Merzig-Schwemmlingen | |
| Germany | Investigational Site, Oldenkirchener Straße 43 | Mönchengladbach | |
| Germany | Investigational Site, Irisstraße 23 | München | |
| Germany | Investigational Site, Theodolindenstraße 97 | München | |
| Germany | Investigational Site, Hammer Straße 95 | Münster | |
| Germany | Investigational Site, Unterer Markt 26/27 | Neumarkt in der Oberpfalz | |
| Germany | Investigational Site, Bahnhofstraße 11 | Nieder-Olm | |
| Germany | Investigational Site, Glogauer Straße 42 | Nürnberg | |
| Germany | Investigational Site, Kleinreuther Weg 88 | Nürnberg | |
| Germany | Investigational Site, Weiltinger Straße 11 | Nürnberg | |
| Germany | Investigational Site, Hauptstraße 19 | Oldenburg | |
| Germany | Investigational Site, Lutherstraße 22 | Oschatz | |
| Germany | Investigational Site, Neue Mitte 6 | Pohlheim | |
| Germany | Investigational Site, Allee nach Sanssouci 7 | Potsdam | |
| Germany | Investigational Site, Dortustraße 4 | Potsdam | |
| Germany | Investigational Site, Großbeerenstraße 301 | Potsdam | |
| Germany | Investigational Site, R.-Breitscheid-Straße 56 | Potsdam | |
| Germany | Investigational Site, Hohenzollernstraße 7 | Recklinghausen | |
| Germany | Investigational Site, Bundesstraße 56 | Roetgen | |
| Germany | Investigational Site, St.-Petersburger Str. 18c | Rostock | |
| Germany | Investigational Site, Heinz-Meise-Straße 101 | Rotenburg | |
| Germany | Investigational Site, Tegernseer Str. 100 | Rottach-Egern | |
| Germany | Investigational Site, Hoerstraße 42 | Rottweil | |
| Germany | Investigational Site, Neustadter Straße 61 | Sonnenberg | |
| Germany | Investigational Site, Winterspürer Straße 11 | Stockach | |
| Germany | Investigational Site, Fichteplatz 1 | Strausberg | |
| Germany | Investigational Site, Am Wallgraben 99 | Stuttgart | |
| Germany | Investigational Site, Industriestraße 4 | Stuttgart | |
| Germany | Investigational Site, Röhre 1 | Sundern | |
| Germany | Investigational Site, Olgastraße 139 | Ulm | |
| Germany | Investigational Site, Am Stutenteich 8 | Waltrop | |
| Germany | Investigational Site, Langenbeckplatz 2 | Wiesbaden | |
| Germany | Investigational Site, Straße von Triptis 12 | Zell |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals | Ferring Arzneimittel GmbH |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prescription habits measured by daily dose of Mesalazine | 0 - 8 weeks | No | |
| Secondary | Compliance measured by questionnaire for drug intake | 0 - 8 weeks | No | |
| Secondary | Quality of Life measured by EuroQol Questionnaire | 0 - 8 weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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