- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01363453
User Surveillance in Ulcerative Colitis (CARE)
May 31, 2011 updated by: Ferring Pharmaceuticals
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aalen, Germany
- Investigational , Karlsplatz 18
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Ansbach, Germany
- Investigational Site, Goethestraße 5
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Aschaffenburg, Germany
- Investigational Site, Elisenstraße 32
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Bad Homburg, Germany
- Investigational Site, Haingasse 22
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Berlin, Germany
- Investigational Site, Blankenburger Chaussee 86
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Berlin, Germany
- Investigational Site, Etkar-André-Straße 8
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Berlin, Germany
- Investigational Site, Mohrenstraße 6
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Berlin, Germany
- Investigational Site, Myslowitzer Straße 49
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Berlin, Germany
- Investigational Site, Schönhauser Allee 129
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Berlin, Germany
- Investigational Site, Karl-Marx-Straße 46
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Berlin, Germany
- Investigational Site, Martin-Luther-Straße 134
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Berlin, Germany
- Investigational Site, Plügerstraße 75
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Birkenfeld, Germany
- Investigational Site, Hauptstraße 13 - 15
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Bochum, Germany
- Investigational Site, Kurt-Schumacher-Platz 4
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Bonn, Germany
- Investigational Site, Münsterstraße 18
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Bonn, Germany
- Investigational Site, Am Burgweiher 54
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Bonn, Germany
- Investigational Site, Kasernenstraße 22 - 24
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Brandenburg, Germany
- Investigational Site, Trauerberg 27/28
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Calw, Germany
- Investigational Site, Hermann-Hesse-Platz 3
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Chemnitz, Germany
- Investigational Site, Moritzstraße 19
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Cloppenburg, Germany
- Investigational Site, Osterstraße 44
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Cottbus, Germany
- Investigational Site, Leipziger Straße 45 b
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Dachau, Germany
- Investigational Site, Münchner Straße 64
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Delitzsch, Germany
- Investigational Site, Schäfergraben 5 H
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Dinslaken, Germany
- Investigational Site, Hans-Böckler-Straße 20
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Düsseldorf, Germany
- Investigational Site, Schadowstraße 42
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Düsseldorf, Germany
- Investigational Site, Simrockstraße 56
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Eberswalde, Germany
- Investigational Site, Ludwig-Sandberg-Straße 4
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Eisenhüttenstadt, Germany
- Investigational Site, Neuzeller Landweg 1
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Elmshorn, Germany
- Investigational Site, Mühlendamm 23
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Erftstadt, Germany
- Investigational Site, Franz-Busbach-Str. 8
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Erfurt, Germany
- Investigational Site, Neuwerkstraße 2
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Essen, Germany
- Investigational Site, Lehmanns Brink 5
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Essen, Germany
- Investigational Site, Steeler Straße 204
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Euskirchen, Germany
- Investigational Site, Viktoriastraße 5
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Forst, Germany
- Investigational Site, Sorauer Straße 56
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Frankfurt Main, Germany
- Investigational Site, Im Prüfling 23
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Frankfurt Main, Germany
- Investigational Site, Pfingstweidestraße 4
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Freising, Germany
- Investigational Site, Finkenstraße 31
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Fulda, Germany
- Investigational Site, Bahnhofstraße 16
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Fürth, Germany
- Investigational Site, Bahnhofplatz 11
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Gelsenkirchen, Germany
- Investigational Site, Straßburger Weg 4
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Goch, Germany
- Investigational Site, Hinter der Mauer 105
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Göttingen, Germany
- Investigational Site, Waldweg 1
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Hagen, Germany
- Investigational Site, Buscheystraße 15 a
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Hamburg, Germany
- Investigational Site, Eppendorfer Baum 35-37
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Hamburg, Germany
- Investigational Site, Drosselstraße 6 A
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Hamburg, Germany
- Investigational Site, Fontenay 1 d
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Hamburg, Germany
- Investigational Site, Propst-Paulsen-Straße 2
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Hamburg, Germany
- Investigational Site, Schweriner Straße 1
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Haßloch, Germany
- Investigational Site, Rathausplatz 4
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Heidelberg, Germany
- Investigational Site, Kurfürstenanlage 34
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Hettstedt, Germany
- Investigational Site, Luisenstraße 18 a
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Hirschberg, Germany
- Investigational Site, Hohensachsener Str. 2
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Hofheim, Germany
- Investigational Site, Robert-Koch-Straße 2
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Hoyerswerda, Germany
- Investigational Site, M.-Grollmuß-Straße 10
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Jerichow, Germany
- Investigational Site, J.-Lange-Straße 20, Haus 7
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Kiel, Germany
- Investigational Site, Goethestraße 11
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Kiel, Germany
- Investigational Site, Poggendörper Weg 3-9
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Koblenz, Germany
- Investigational Site, Markenbildchenweg 30
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Konigstein im Taunus, Germany
- Investigational Site, Herzog-Adolph-Straße 13
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Kronach, Germany
- Investigational Site, Friesener Straße 41
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Köthen, Germany
- Investigational Site, Schalaunische Strape 6/7
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Lindau, Germany
- Investigational Site, Auf dem Wall 6
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Ludwigsfelde, Germany
- Investigational Site, Potsdamer Straße 120A
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Ludwigshafen, Germany
- Investigational Site, Rheingönheimer Str. 121
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Ludwigshafen, Germany
- Investigational Site, Weißdornhag 2
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Lübeck, Germany
- Investigational Site, Königstraße 81
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Magdeburg, Germany
- Investigational Site, Pfeifferstraße 10
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Mainz, Germany
- Investigational Site, Weißliliengasse 31
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Mannheim, Germany
- Investigational Site, Auf dem Sand 76a
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Merzig, Germany
- Investigational Site, Zur Stadthalle 2
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Merzig-Schwemmlingen, Germany
- Investigational Site, Zum Schotzberg 1 a
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Mönchengladbach, Germany
- Investigational Site, Oldenkirchener Straße 43
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München, Germany
- Investigational Site, Irisstraße 23
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München, Germany
- Investigational Site, Theodolindenstraße 97
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Münster, Germany
- Investigational Site, Hammer Straße 95
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Neumarkt in der Oberpfalz, Germany
- Investigational Site, Unterer Markt 26/27
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Nieder-Olm, Germany
- Investigational Site, Bahnhofstraße 11
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Nürnberg, Germany
- Investigational Site, Glogauer Straße 42
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Nürnberg, Germany
- Investigational Site, Weiltinger Straße 11
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Nürnberg, Germany
- Investigational Site, Kleinreuther Weg 88
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Oldenburg, Germany
- Investigational Site, Hauptstraße 19
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Oschatz, Germany
- Investigational Site, Lutherstraße 22
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Pohlheim, Germany
- Investigational Site, Neue Mitte 6
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Potsdam, Germany
- Investigational Site, Großbeerenstraße 301
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Potsdam, Germany
- Investigational Site, R.-Breitscheid-Straße 56
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Potsdam, Germany
- Investigational Site, Allee nach Sanssouci 7
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Potsdam, Germany
- Investigational Site, Dortustraße 4
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Recklinghausen, Germany
- Investigational Site, Hohenzollernstraße 7
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Roetgen, Germany
- Investigational Site, Bundesstraße 56
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Rostock, Germany
- Investigational Site, St.-Petersburger Str. 18c
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Rotenburg, Germany
- Investigational Site, Heinz-Meise-Straße 101
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Rottach-Egern, Germany
- Investigational Site, Tegernseer Str. 100
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Rottweil, Germany
- Investigational Site, Hoerstraße 42
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Sonnenberg, Germany
- Investigational Site, Neustadter Straße 61
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Stockach, Germany
- Investigational Site, Winterspürer Straße 11
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Strausberg, Germany
- Investigational Site, Fichteplatz 1
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Stuttgart, Germany
- Investigational Site, Am Wallgraben 99
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Stuttgart, Germany
- Investigational Site, Industriestraße 4
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Sundern, Germany
- Investigational Site, Röhre 1
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Ulm, Germany
- Investigational Site, Olgastraße 139
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Waltrop, Germany
- Investigational Site, Am Stutenteich 8
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Wiesbaden, Germany
- Investigational Site, Langenbeckplatz 2
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Zell, Germany
- Investigational Site, Straße von Triptis 12
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Private practices
Description
Inclusion Criteria:
- therapeutic need according to SPC
- written informed consent
Exclusion Criteria:
- contraindications according to SPC
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with Ulcerative Colitis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Prescription habits measured by daily dose of Mesalazine
Time Frame: 0 - 8 weeks
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0 - 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Compliance measured by questionnaire for drug intake
Time Frame: 0 - 8 weeks
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0 - 8 weeks
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Quality of Life measured by EuroQol Questionnaire
Time Frame: 0 - 8 weeks
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0 - 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
May 30, 2011
First Submitted That Met QC Criteria
May 31, 2011
First Posted (Estimate)
June 1, 2011
Study Record Updates
Last Update Posted (Estimate)
June 1, 2011
Last Update Submitted That Met QC Criteria
May 31, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FE999907
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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