User Surveillance in Ulcerative Colitis

NCT01363453 | Completed

• 1 other identifier: FE999907
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 105

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Prescription habits measured by daily dose of Mesalazine

  0 - 8 weeks

Secondary Outcomes (2)

• Compliance measured by questionnaire for drug intake

  0 - 8 weeks

• Quality of Life measured by EuroQol Questionnaire

  0 - 8 weeks

Study Arms (1)

Patients with Ulcerative Colitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Private practices

You may qualify if:

• therapeutic need according to SPC
• written informed consent

You may not qualify if:

• contraindications according to SPC

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead
• Ferring Arzneimittel GmbH: collaborator

Study Sites (105)

Investigational , Karlsplatz 18

Aalen, Germany

Location

Investigational Site, Goethestraße 5

Ansbach, Germany

Location

Investigational Site, Elisenstraße 32

Aschaffenburg, Germany

Location

Investigational Site, Haingasse 22

Bad Homburg, Germany

Location

Investigational Site, Blankenburger Chaussee 86

Berlin, Germany

Location

Investigational Site, Etkar-André-Straße 8

Berlin, Germany

Location

Investigational Site, Karl-Marx-Straße 46

Berlin, Germany

Location

Investigational Site, Martin-Luther-Straße 134

Berlin, Germany

Location

Investigational Site, Mohrenstraße 6

Berlin, Germany

Location

Investigational Site, Myslowitzer Straße 49

Berlin, Germany

Location

Investigational Site, Plügerstraße 75

Berlin, Germany

Location

Investigational Site, Schönhauser Allee 129

Berlin, Germany

Location

Investigational Site, Hauptstraße 13 - 15

Birkenfeld, Germany

Location

Investigational Site, Kurt-Schumacher-Platz 4

Bochum, Germany

Location

Investigational Site, Am Burgweiher 54

Bonn, Germany

Location

Investigational Site, Kasernenstraße 22 - 24

Bonn, Germany

Location

Investigational Site, Münsterstraße 18

Bonn, Germany

Location

Investigational Site, Trauerberg 27/28

Brandenburg, Germany

Location

Investigational Site, Hermann-Hesse-Platz 3

Calw, Germany

Location

Investigational Site, Moritzstraße 19

Chemnitz, Germany

Location

Investigational Site, Osterstraße 44

Cloppenburg, Germany

Location

Investigational Site, Leipziger Straße 45 b

Cottbus, Germany

Location

Investigational Site, Münchner Straße 64

Dachau, Germany

Location

Investigational Site, Schäfergraben 5 H

Delitzsch, Germany

Location

Investigational Site, Hans-Böckler-Straße 20

Dinslaken, Germany

Location

Investigational Site, Schadowstraße 42

Düsseldorf, Germany

Location

Investigational Site, Simrockstraße 56

Düsseldorf, Germany

Location

Investigational Site, Ludwig-Sandberg-Straße 4

Eberswalde, Germany

Location

Investigational Site, Neuzeller Landweg 1

Eisenhüttenstadt, Germany

Location

Investigational Site, Mühlendamm 23

Elmshorn, Germany

Location

Investigational Site, Franz-Busbach-Str. 8

Erftstadt, Germany

Location

Investigational Site, Neuwerkstraße 2

Erfurt, Germany

Location

Investigational Site, Lehmanns Brink 5

Essen, Germany

Location

Investigational Site, Steeler Straße 204

Essen, Germany

Location

Investigational Site, Viktoriastraße 5

Euskirchen, Germany

Location

Investigational Site, Sorauer Straße 56

Forst, Germany

Location

Investigational Site, Im Prüfling 23

Frankfurt am Main, Germany

Location

Investigational Site, Pfingstweidestraße 4

Frankfurt am Main, Germany

Location

Investigational Site, Finkenstraße 31

Freising, Germany

Location

Investigational Site, Bahnhofstraße 16

Fulda, Germany

Location

Investigational Site, Bahnhofplatz 11

Fürth, Germany

Location

Investigational Site, Straßburger Weg 4

Gelsenkirchen, Germany

Location

Investigational Site, Hinter der Mauer 105

Goch, Germany

Location

Investigational Site, Waldweg 1

Göttingen, Germany

Location

Investigational Site, Buscheystraße 15 a

Hagen, Germany

Location

Investigational Site, Drosselstraße 6 A

Hamburg, Germany

Location

Investigational Site, Eppendorfer Baum 35-37

Hamburg, Germany

Location

Investigational Site, Fontenay 1 d

Hamburg, Germany

Location

Investigational Site, Propst-Paulsen-Straße 2

Hamburg, Germany

Location

Investigational Site, Schweriner Straße 1

Hamburg, Germany

Location

Investigational Site, Rathausplatz 4

Haßloch, Germany

Location

Investigational Site, Kurfürstenanlage 34

Heidelberg, Germany

Location

Investigational Site, Luisenstraße 18 a

Hettstedt, Germany

Location

Investigational Site, Hohensachsener Str. 2

Hirschberg, Germany

Location

Investigational Site, Robert-Koch-Straße 2

Hofheim, Germany

Location

Investigational Site, M.-Grollmuß-Straße 10

Hoyerswerda, Germany

Location

Investigational Site, J.-Lange-Straße 20, Haus 7

Jerichow, Germany

Location

Investigational Site, Goethestraße 11

Kiel, Germany

Location

Investigational Site, Poggendörper Weg 3-9

Kiel, Germany

Location

Investigational Site, Markenbildchenweg 30

Koblenz, Germany

Location

Investigational Site, Herzog-Adolph-Straße 13

Königstein im Taunus, Germany

Location

Investigational Site, Schalaunische Strape 6/7

Köthen, Germany

Location

Investigational Site, Friesener Straße 41

Kronach, Germany

Location

Investigational Site, Auf dem Wall 6

Lindau, Germany

Location

Investigational Site, Potsdamer Straße 120A

Ludwigsfelde, Germany

Location

Investigational Site, Rheingönheimer Str. 121

Ludwigshafen, Germany

Location

Investigational Site, Weißdornhag 2

Ludwigshafen, Germany

Location

Investigational Site, Königstraße 81

Lübeck, Germany

Location

Investigational Site, Pfeifferstraße 10

Magdeburg, Germany

Location

Investigational Site, Weißliliengasse 31

Mainz, Germany

Location

Investigational Site, Auf dem Sand 76a

Mannheim, Germany

Location

Investigational Site, Zur Stadthalle 2

Merzig, Germany

Location

Investigational Site, Zum Schotzberg 1 a

Merzig-Schwemmlingen, Germany

Location

Investigational Site, Oldenkirchener Straße 43

Mönchengladbach, Germany

Location

Investigational Site, Irisstraße 23

München, Germany

Location

Investigational Site, Theodolindenstraße 97

München, Germany

Location

Investigational Site, Hammer Straße 95

Münster, Germany

Location

Investigational Site, Unterer Markt 26/27

Neumarkt in der Oberpfalz, Germany

Location

Investigational Site, Bahnhofstraße 11

Nieder-Olm, Germany

Location

Investigational Site, Glogauer Straße 42

Nuremberg, Germany

Location

Investigational Site, Kleinreuther Weg 88

Nuremberg, Germany

Location

Investigational Site, Weiltinger Straße 11

Nuremberg, Germany

Location

Investigational Site, Hauptstraße 19

Oldenburg, Germany

Location

Investigational Site, Lutherstraße 22

Oschatz, Germany

Location

Investigational Site, Neue Mitte 6

Pohlheim, Germany

Location

Investigational Site, Allee nach Sanssouci 7

Potsdam, Germany

Location

Investigational Site, Dortustraße 4

Potsdam, Germany

Location

Investigational Site, Großbeerenstraße 301

Potsdam, Germany

Location

Investigational Site, R.-Breitscheid-Straße 56

Potsdam, Germany

Location

Investigational Site, Hohenzollernstraße 7

Recklinghausen, Germany

Location

Investigational Site, Bundesstraße 56

Roetgen, Germany

Location

Investigational Site, St.-Petersburger Str. 18c

Rostock, Germany

Location

Investigational Site, Heinz-Meise-Straße 101

Rotenburg (Wümme), Germany

Location

Investigational Site, Tegernseer Str. 100

Rottach-Egern, Germany

Location

Investigational Site, Hoerstraße 42

Rottweil, Germany

Location

Investigational Site, Neustadter Straße 61

Sonnenberg, Germany

Location

Investigational Site, Winterspürer Straße 11

Stockach, Germany

Location

Investigational Site, Fichteplatz 1

Strausberg, Germany

Location

Investigational Site, Am Wallgraben 99

Stuttgart, Germany

Location

Investigational Site, Industriestraße 4

Stuttgart, Germany

Location

Investigational Site, Röhre 1

Sundern, Germany

Location

Investigational Site, Olgastraße 139

Ulm, Germany

Location

Investigational Site, Am Stutenteich 8

Waltrop, Germany

Location

Investigational Site, Langenbeckplatz 2

Wiesbaden, Germany

Location

Investigational Site, Straße von Triptis 12

Zell, Germany

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 30, 2011
• First Posted: June 1, 2011
• Study Start: October 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 1, 2011

Record last verified: 2011-05

Locations

DE (105)