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Ulcerative ColitisCARENCT01363453

User Surveillance in Ulcerative Colitis

An observational study of Ulcerative Colitis, run by Ferring Pharmaceuticals at 105 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
How many people
500 participants
Where
105 sitesGermany
Study dates
Oct 2007to Jul 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Private practices

Who may be able to join

  • therapeutic need according to SPC
  • written informed consent

Who cannot join

  • contraindications according to SPC

Trial locations and contacts

105 sites in 1 country.

105 sites in 1 country

Germany105 sites

  • Investigational , Karlsplatz 18

    Aalen

  • Investigational Site, Goethestraße 5

    Ansbach

  • Investigational Site, Elisenstraße 32

    Aschaffenburg

  • Investigational Site, Haingasse 22

    Bad Homburg

  • Investigational Site, Blankenburger Chaussee 86

    Berlin

  • Investigational Site, Etkar-André-Straße 8

    Berlin

  • Investigational Site, Karl-Marx-Straße 46

    Berlin

  • Investigational Site, Martin-Luther-Straße 134

    Berlin

  • Investigational Site, Mohrenstraße 6

    Berlin

  • Investigational Site, Myslowitzer Straße 49

    Berlin

  • Investigational Site, Plügerstraße 75

    Berlin

  • Investigational Site, Schönhauser Allee 129

    Berlin

  • Investigational Site, Hauptstraße 13 - 15

    Birkenfeld

  • Investigational Site, Kurt-Schumacher-Platz 4

    Bochum

  • Investigational Site, Am Burgweiher 54

    Bonn

  • Investigational Site, Kasernenstraße 22 - 24

    Bonn

  • Investigational Site, Münsterstraße 18

    Bonn

  • Investigational Site, Trauerberg 27/28

    Brandenburg

  • Investigational Site, Hermann-Hesse-Platz 3

    Calw

  • Investigational Site, Moritzstraße 19

    Chemnitz

  • Investigational Site, Osterstraße 44

    Cloppenburg

  • Investigational Site, Leipziger Straße 45 b

    Cottbus

  • Investigational Site, Münchner Straße 64

    Dachau

  • Investigational Site, Schäfergraben 5 H

    Delitzsch

  • Investigational Site, Hans-Böckler-Straße 20

    Dinslaken

  • Investigational Site, Schadowstraße 42

    Düsseldorf

  • Investigational Site, Simrockstraße 56

    Düsseldorf

  • Investigational Site, Ludwig-Sandberg-Straße 4

    Eberswalde

  • Investigational Site, Neuzeller Landweg 1

    Eisenhüttenstadt

  • Investigational Site, Mühlendamm 23

    Elmshorn

  • Investigational Site, Franz-Busbach-Str. 8

    Erftstadt

  • Investigational Site, Neuwerkstraße 2

    Erfurt

  • Investigational Site, Lehmanns Brink 5

    Essen

  • Investigational Site, Steeler Straße 204

    Essen

  • Investigational Site, Viktoriastraße 5

    Euskirchen

  • Investigational Site, Sorauer Straße 56

    Forst

  • Investigational Site, Im Prüfling 23

    Frankfurt am Main

  • Investigational Site, Pfingstweidestraße 4

    Frankfurt am Main

  • Investigational Site, Finkenstraße 31

    Freising

  • Investigational Site, Bahnhofstraße 16

    Fulda

  • Investigational Site, Bahnhofplatz 11

    Fürth

  • Investigational Site, Straßburger Weg 4

    Gelsenkirchen

  • Investigational Site, Hinter der Mauer 105

    Goch

  • Investigational Site, Waldweg 1

    Göttingen

  • Investigational Site, Buscheystraße 15 a

    Hagen

  • Investigational Site, Drosselstraße 6 A

    Hamburg

  • Investigational Site, Eppendorfer Baum 35-37

    Hamburg

  • Investigational Site, Fontenay 1 d

    Hamburg

  • Investigational Site, Propst-Paulsen-Straße 2

    Hamburg

  • Investigational Site, Schweriner Straße 1

    Hamburg

  • Investigational Site, Rathausplatz 4

    Haßloch

  • Investigational Site, Kurfürstenanlage 34

    Heidelberg

  • Investigational Site, Luisenstraße 18 a

    Hettstedt

  • Investigational Site, Hohensachsener Str. 2

    Hirschberg

  • Investigational Site, Robert-Koch-Straße 2

    Hofheim

  • Investigational Site, M.-Grollmuß-Straße 10

    Hoyerswerda

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

    Jerichow

  • Investigational Site, Goethestraße 11

    Kiel

  • Investigational Site, Poggendörper Weg 3-9

    Kiel

  • Investigational Site, Markenbildchenweg 30

    Koblenz

  • Investigational Site, Herzog-Adolph-Straße 13

    Königstein im Taunus

  • Investigational Site, Schalaunische Strape 6/7

    Köthen

  • Investigational Site, Friesener Straße 41

    Kronach

  • Investigational Site, Auf dem Wall 6

    Lindau

  • Investigational Site, Königstraße 81

    Lübeck

  • Investigational Site, Potsdamer Straße 120A

    Ludwigsfelde

  • Investigational Site, Rheingönheimer Str. 121

    Ludwigshafen

  • Investigational Site, Weißdornhag 2

    Ludwigshafen

  • Investigational Site, Pfeifferstraße 10

    Magdeburg

  • Investigational Site, Weißliliengasse 31

    Mainz

  • Investigational Site, Auf dem Sand 76a

    Mannheim

  • Investigational Site, Zur Stadthalle 2

    Merzig

  • Investigational Site, Zum Schotzberg 1 a

    Merzig-Schwemmlingen

  • Investigational Site, Oldenkirchener Straße 43

    Mönchengladbach

  • Investigational Site, Irisstraße 23

    München

  • Investigational Site, Theodolindenstraße 97

    München

  • Investigational Site, Hammer Straße 95

    Münster

  • Investigational Site, Unterer Markt 26/27

    Neumarkt in der Oberpfalz

  • Investigational Site, Bahnhofstraße 11

    Nieder-Olm

  • Investigational Site, Glogauer Straße 42

    Nuremberg

  • Investigational Site, Kleinreuther Weg 88

    Nuremberg

  • Investigational Site, Weiltinger Straße 11

    Nuremberg

  • Investigational Site, Hauptstraße 19

    Oldenburg

  • Investigational Site, Lutherstraße 22

    Oschatz

  • Investigational Site, Neue Mitte 6

    Pohlheim

  • Investigational Site, Allee nach Sanssouci 7

    Potsdam

  • Investigational Site, Dortustraße 4

    Potsdam

  • Investigational Site, Großbeerenstraße 301

    Potsdam

  • Investigational Site, R.-Breitscheid-Straße 56

    Potsdam

  • Investigational Site, Hohenzollernstraße 7

    Recklinghausen

  • Investigational Site, Bundesstraße 56

    Roetgen

  • Investigational Site, St.-Petersburger Str. 18c

    Rostock

  • Investigational Site, Heinz-Meise-Straße 101

    Rotenburg (Wümme)

  • Investigational Site, Tegernseer Str. 100

    Rottach-Egern

  • Investigational Site, Hoerstraße 42

    Rottweil

  • Investigational Site, Neustadter Straße 61

    Sonnenberg

  • Investigational Site, Winterspürer Straße 11

    Stockach

  • Investigational Site, Fichteplatz 1

    Strausberg

  • Investigational Site, Am Wallgraben 99

    Stuttgart

  • Investigational Site, Industriestraße 4

    Stuttgart

  • Investigational Site, Röhre 1

    Sundern

  • Investigational Site, Olgastraße 139

    Ulm

  • Investigational Site, Am Stutenteich 8

    Waltrop

  • Investigational Site, Langenbeckplatz 2

    Wiesbaden

  • Investigational Site, Straße von Triptis 12

    Zell

Other trials in Germany

About this study

Official 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.

Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01363453
Study groupRoleWhat they receive
Patients with Ulcerative ColitisNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prescription habits measured by daily dose of Mesalazine

    Measured: 0 - 8 weeks

Secondary outcomes (2)

  1. Compliance measured by questionnaire for drug intake

    Measured: 0 - 8 weeks

  2. Quality of Life measured by EuroQol Questionnaire

    Measured: 0 - 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2011 (estimated)
  2. Study startOct 2007
  3. Primary completionMay 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01363453
Sponsor's protocol ID
FE999907
Acronym
CARE
Status last verified
May 2011
First submitted
30 May 2011
Last updated
1 Jun 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by Ferring Pharmaceuticals at 105 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prescription habits measured by daily dose of Mesalazine (time frame: 0 - 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01363453.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2011.

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