User Surveillance in Ulcerative Colitis (CARE)

This study has been completed.
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01363453
First received: May 30, 2011
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

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.


Condition
Ulcerative Colitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acute and Remission Therapy of Ulcerative Colitis With Oral Mesalazine

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Prescription habits measured by daily dose of Mesalazine [ Time Frame: 0 - 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance measured by questionnaire for drug intake [ Time Frame: 0 - 8 weeks ] [ Designated as safety issue: No ]
  • Quality of Life measured by EuroQol Questionnaire [ Time Frame: 0 - 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Ulcerative Colitis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Private practices

Criteria

Inclusion Criteria:

  • therapeutic need according to SPC
  • written informed consent

Exclusion Criteria:

  • contraindications according to SPC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363453

  Hide Study Locations
Locations
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, Plügerstraße 75
Berlin, Germany
Investigational Site, Myslowitzer Straße 49
Berlin, Germany
Investigational Site, Martin-Luther-Straße 134
Berlin, Germany
Investigational Site, Karl-Marx-Straße 46
Berlin, Germany
Investigational Site, Blankenburger Chaussee 86
Berlin, Germany
Investigational Site, Schönhauser Allee 129
Berlin, Germany
Investigational Site, Etkar-André-Straße 8
Berlin, Germany
Investigational Site, Mohrenstraße 6
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, Simrockstraße 56
Düsseldorf, Germany
Investigational Site, Schadowstraße 42
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, Steeler Straße 204
Essen, Germany
Investigational Site, Lehmanns Brink 5
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, Schweriner Straße 1
Hamburg, Germany
Investigational Site, Fontenay 1 d
Hamburg, Germany
Investigational Site, Drosselstraße 6 A
Hamburg, Germany
Investigational Site, Eppendorfer Baum 35-37
Hamburg, Germany
Investigational Site, Propst-Paulsen-Straße 2
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, Friesener Straße 41
Kronach, Germany
Investigational Site, Schalaunische Strape 6/7
Köthen, Germany
Investigational Site, Auf dem Wall 6
Lindau, Germany
Investigational Site, Potsdamer Straße 120A
Ludwigsfelde, Germany
Investigational Site, Rheingönheimer Str. 121
Ludwigshafen, Germany
Investigational Site, Weißdornhag 2
Ludwigshafen, Germany
Investigational Site, Königstraße 81
Lübeck, 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, Kleinreuther Weg 88
Nürnberg, Germany
Investigational Site, Weiltinger Straße 11
Nürnberg, Germany
Investigational Site, Glogauer Straße 42
Nürnberg, Germany
Investigational Site, Hauptstraße 19
Oldenburg, Germany
Investigational Site, Lutherstraße 22
Oschatz, Germany
Investigational Site, Neue Mitte 6
Pohlheim, Germany
Investigational Site, R.-Breitscheid-Straße 56
Potsdam, Germany
Investigational Site, Allee nach Sanssouci 7
Potsdam, Germany
Investigational Site, Großbeerenstraße 301
Potsdam, Germany
Investigational Site, Dortustraße 4
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, Germany
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01363453     History of Changes
Other Study ID Numbers: FE999907
Study First Received: May 30, 2011
Last Updated: May 31, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014