Clinical trial NCT01363453: User Surveillance in Ulcerative Colitis
Official title: Acute and Remission Therapy of Ulcerative Colitis With Oral Mesalazine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Ferring Arzneimittel GmbH
First posted: 2011-06-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Private practices

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* therapeutic need according to SPC
* written informed consent

Exclusion Criteria:

* contraindications according to SPC

Primary outcomes:
measure: Prescription habits measured by daily dose of Mesalazine
timeFrame: 0 - 8 weeks
Secondary outcomes:
measure: Compliance measured by questionnaire for drug intake
timeFrame: 0 - 8 weeks
measure: Quality of Life measured by EuroQol Questionnaire
timeFrame: 0 - 8 weeks
Other outcomes:
Locations:
city: Aalen
country: Germany
facility: Investigational , Karlsplatz 18
city: Ansbach
country: Germany
facility: Investigational Site, Goethestraße 5
city: Aschaffenburg
country: Germany
facility: Investigational Site, Elisenstraße 32
city: Bad Homburg
country: Germany
facility: Investigational Site, Haingasse 22
city: Berlin
country: Germany
facility: Investigational Site, Blankenburger Chaussee 86
city: Berlin
country: Germany
facility: Investigational Site, Etkar-André-Straße 8
city: Berlin
country: Germany
facility: Investigational Site, Karl-Marx-Straße 46
city: Berlin
country: Germany
facility: Investigational Site, Martin-Luther-Straße 134
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, Plügerstraße 75
city: Berlin
country: Germany
facility: Investigational Site, Schönhauser Allee 129
city: Birkenfeld
country: Germany
facility: Investigational Site, Hauptstraße 13 - 15
city: Bochum
country: Germany
facility: Investigational Site, Kurt-Schumacher-Platz 4
city: Bonn
country: Germany
facility: Investigational Site, Am Burgweiher 54
city: Bonn
country: Germany
facility: Investigational Site, Kasernenstraße 22 - 24
city: Bonn
country: Germany
facility: Investigational Site, Münsterstraße 18
city: Brandenburg
country: Germany
facility: Investigational Site, Trauerberg 27/28
city: Calw
country: Germany
facility: Investigational Site, Hermann-Hesse-Platz 3
city: Chemnitz
country: Germany
facility: Investigational Site, Moritzstraße 19
city: Cloppenburg
country: Germany
facility: Investigational Site, Osterstraße 44
city: Cottbus
country: Germany
facility: Investigational Site, Leipziger Straße 45 b
city: Dachau
country: Germany
facility: Investigational Site, Münchner Straße 64
city: Delitzsch
country: Germany
facility: Investigational Site, Schäfergraben 5 H
city: Dinslaken
country: Germany
facility: Investigational Site, Hans-Böckler-Straße 20
city: Düsseldorf
country: Germany
facility: Investigational Site, Schadowstraße 42
city: Düsseldorf
country: Germany
facility: Investigational Site, Simrockstraße 56
city: Eberswalde
country: Germany
facility: Investigational Site, Ludwig-Sandberg-Straße 4
city: Eisenhüttenstadt
country: Germany
facility: Investigational Site, Neuzeller Landweg 1
city: Elmshorn
country: Germany
facility: Investigational Site, Mühlendamm 23
city: Erftstadt
country: Germany
facility: Investigational Site, Franz-Busbach-Str. 8
city: Erfurt
country: Germany
facility: Investigational Site, Neuwerkstraße 2
city: Essen
country: Germany
facility: Investigational Site, Lehmanns Brink 5
city: Essen
country: Germany
facility: Investigational Site, Steeler Straße 204
city: Euskirchen
country: Germany
facility: Investigational Site, Viktoriastraße 5
city: Forst
country: Germany
facility: Investigational Site, Sorauer Straße 56
city: Frankfurt Main
country: Germany
facility: Investigational Site, Im Prüfling 23
city: Frankfurt Main
country: Germany
facility: Investigational Site, Pfingstweidestraße 4
city: Freising
country: Germany
facility: Investigational Site, Finkenstraße 31
city: Fulda
country: Germany
facility: Investigational Site, Bahnhofstraße 16
city: Fürth
country: Germany
facility: Investigational Site, Bahnhofplatz 11
city: Gelsenkirchen
country: Germany
facility: Investigational Site, Straßburger Weg 4
city: Goch
country: Germany
facility: Investigational Site, Hinter der Mauer 105
city: Göttingen
country: Germany
facility: Investigational Site, Waldweg 1
city: Hagen
country: Germany
facility: Investigational Site, Buscheystraße 15 a
city: Hamburg
country: Germany
facility: Investigational Site, Drosselstraße 6 A
city: Hamburg
country: Germany
facility: Investigational Site, Eppendorfer Baum 35-37
city: Hamburg
country: Germany
facility: Investigational Site, Fontenay 1 d
city: Hamburg
country: Germany
facility: Investigational Site, Propst-Paulsen-Straße 2
city: Hamburg
country: Germany
facility: Investigational Site, Schweriner Straße 1
city: Haßloch
country: Germany
facility: Investigational Site, Rathausplatz 4
city: Heidelberg
country: Germany
facility: Investigational Site, Kurfürstenanlage 34
city: Hettstedt
country: Germany
facility: Investigational Site, Luisenstraße 18 a
city: Hirschberg
country: Germany
facility: Investigational Site, Hohensachsener Str. 2
city: Hofheim
country: Germany
facility: Investigational Site, Robert-Koch-Straße 2
city: Hoyerswerda
country: Germany
facility: Investigational Site, M.-Grollmuß-Straße 10
city: Jerichow
country: Germany
facility: Investigational Site, J.-Lange-Straße 20, Haus 7
city: Kiel
country: Germany
facility: Investigational Site, Goethestraße 11
city: Kiel
country: Germany
facility: Investigational Site, Poggendörper Weg 3-9
city: Koblenz
country: Germany
facility: Investigational Site, Markenbildchenweg 30
city: Konigstein im Taunus
country: Germany
facility: Investigational Site, Herzog-Adolph-Straße 13
city: Kronach
country: Germany
facility: Investigational Site, Friesener Straße 41
city: Köthen
country: Germany
facility: Investigational Site, Schalaunische Strape 6/7
city: Lindau
country: Germany
facility: Investigational Site, Auf dem Wall 6
city: Ludwigsfelde
country: Germany
facility: Investigational Site, Potsdamer Straße 120A
city: Ludwigshafen
country: Germany
facility: Investigational Site, Rheingönheimer Str. 121
city: Ludwigshafen
country: Germany
facility: Investigational Site, Weißdornhag 2
city: Lübeck
country: Germany
facility: Investigational Site, Königstraße 81
city: Magdeburg
country: Germany
facility: Investigational Site, Pfeifferstraße 10
city: Mainz
country: Germany
facility: Investigational Site, Weißliliengasse 31
city: Mannheim
country: Germany
facility: Investigational Site, Auf dem Sand 76a
city: Merzig-Schwemmlingen
country: Germany
facility: Investigational Site, Zum Schotzberg 1 a
city: Merzig
country: Germany
facility: Investigational Site, Zur Stadthalle 2
city: Mönchengladbach
country: Germany
facility: Investigational Site, Oldenkirchener Straße 43
city: München
country: Germany
facility: Investigational Site, Irisstraße 23
city: München
country: Germany
facility: Investigational Site, Theodolindenstraße 97
city: Münster
country: Germany
facility: Investigational Site, Hammer Straße 95
city: Neumarkt in der Oberpfalz
country: Germany
facility: Investigational Site, Unterer Markt 26/27
city: Nieder-Olm
country: Germany
facility: Investigational Site, Bahnhofstraße 11
city: Nürnberg
country: Germany
facility: Investigational Site, Glogauer Straße 42
city: Nürnberg
country: Germany
facility: Investigational Site, Kleinreuther Weg 88
city: Nürnberg
country: Germany
facility: Investigational Site, Weiltinger Straße 11
city: Oldenburg
country: Germany
facility: Investigational Site, Hauptstraße 19
city: Oschatz
country: Germany
facility: Investigational Site, Lutherstraße 22
city: Pohlheim
country: Germany
facility: Investigational Site, Neue Mitte 6
city: Potsdam
country: Germany
facility: Investigational Site, Allee nach Sanssouci 7
city: Potsdam
country: Germany
facility: Investigational Site, Dortustraße 4
city: Potsdam
country: Germany
facility: Investigational Site, Großbeerenstraße 301
city: Potsdam
country: Germany
facility: Investigational Site, R.-Breitscheid-Straße 56
city: Recklinghausen
country: Germany
facility: Investigational Site, Hohenzollernstraße 7
city: Roetgen
country: Germany
facility: Investigational Site, Bundesstraße 56
city: Rostock
country: Germany
facility: Investigational Site, St.-Petersburger Str. 18c
city: Rotenburg
country: Germany
facility: Investigational Site, Heinz-Meise-Straße 101
city: Rottach-Egern
country: Germany
facility: Investigational Site, Tegernseer Str. 100
city: Rottweil
country: Germany
facility: Investigational Site, Hoerstraße 42
city: Sonnenberg
country: Germany
facility: Investigational Site, Neustadter Straße 61
city: Stockach
country: Germany
facility: Investigational Site, Winterspürer Straße 11
city: Strausberg
country: Germany
facility: Investigational Site, Fichteplatz 1
city: Stuttgart
country: Germany
facility: Investigational Site, Am Wallgraben 99
city: Stuttgart
country: Germany
facility: Investigational Site, Industriestraße 4
city: Sundern
country: Germany
facility: Investigational Site, Röhre 1
city: Ulm
country: Germany
facility: Investigational Site, Olgastraße 139
city: Waltrop
country: Germany
facility: Investigational Site, Am Stutenteich 8
city: Wiesbaden
country: Germany
facility: Investigational Site, Langenbeckplatz 2
city: Zell
country: Germany
facility: Investigational Site, Straße von Triptis 12
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: