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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Germany
      • Aalen, Germany
        • Investigational , Karlsplatz 18
      • Ansbach, Germany
        • Investigational Site, Goethestraße 5
      • Aschaffenburg, Germany
        • Investigational Site, Elisenstraße 32
      • Bad Homburg, Germany
        • Investigational Site, Haingasse 22
      • Berlin, Germany
        • Investigational Site, Blankenburger Chaussee 86
      • Berlin, Germany
        • Investigational Site, Etkar-André-Straße 8
      • Berlin, Germany
        • Investigational Site, Mohrenstraße 6
      • Berlin, Germany
        • Investigational Site, Myslowitzer Straße 49
      • Berlin, Germany
        • Investigational Site, Schönhauser Allee 129
      • Berlin, Germany
        • Investigational Site, Karl-Marx-Straße 46
      • Berlin, Germany
        • Investigational Site, Martin-Luther-Straße 134
      • Berlin, Germany
        • Investigational Site, Plügerstraße 75
      • Birkenfeld, Germany
        • Investigational Site, Hauptstraße 13 - 15
      • Bochum, Germany
        • Investigational Site, Kurt-Schumacher-Platz 4
      • Bonn, Germany
        • Investigational Site, Münsterstraße 18
      • Bonn, Germany
        • Investigational Site, Am Burgweiher 54
      • Bonn, Germany
        • Investigational Site, Kasernenstraße 22 - 24
      • Brandenburg, Germany
        • Investigational Site, Trauerberg 27/28
      • Calw, Germany
        • Investigational Site, Hermann-Hesse-Platz 3
      • Chemnitz, Germany
        • Investigational Site, Moritzstraße 19
      • Cloppenburg, Germany
        • Investigational Site, Osterstraße 44
      • Cottbus, Germany
        • Investigational Site, Leipziger Straße 45 b
      • Dachau, Germany
        • Investigational Site, Münchner Straße 64
      • Delitzsch, Germany
        • Investigational Site, Schäfergraben 5 H
      • Dinslaken, Germany
        • Investigational Site, Hans-Böckler-Straße 20
      • Düsseldorf, Germany
        • Investigational Site, Schadowstraße 42
      • Düsseldorf, Germany
        • Investigational Site, Simrockstraße 56
      • Eberswalde, Germany
        • Investigational Site, Ludwig-Sandberg-Straße 4
      • Eisenhüttenstadt, Germany
        • Investigational Site, Neuzeller Landweg 1
      • Elmshorn, Germany
        • Investigational Site, Mühlendamm 23
      • Erftstadt, Germany
        • Investigational Site, Franz-Busbach-Str. 8
      • Erfurt, Germany
        • Investigational Site, Neuwerkstraße 2
      • Essen, Germany
        • Investigational Site, Lehmanns Brink 5
      • Essen, Germany
        • Investigational Site, Steeler Straße 204
      • Euskirchen, Germany
        • Investigational Site, Viktoriastraße 5
      • Forst, Germany
        • Investigational Site, Sorauer Straße 56
      • Frankfurt Main, Germany
        • Investigational Site, Im Prüfling 23
      • Frankfurt Main, Germany
        • Investigational Site, Pfingstweidestraße 4
      • Freising, Germany
        • Investigational Site, Finkenstraße 31
      • Fulda, Germany
        • Investigational Site, Bahnhofstraße 16
      • Fürth, Germany
        • Investigational Site, Bahnhofplatz 11
      • Gelsenkirchen, Germany
        • Investigational Site, Straßburger Weg 4
      • Goch, Germany
        • Investigational Site, Hinter der Mauer 105
      • Göttingen, Germany
        • Investigational Site, Waldweg 1
      • Hagen, Germany
        • Investigational Site, Buscheystraße 15 a
      • Hamburg, Germany
        • Investigational Site, Eppendorfer Baum 35-37
      • Hamburg, Germany
        • Investigational Site, Drosselstraße 6 A
      • Hamburg, Germany
        • Investigational Site, Fontenay 1 d
      • Hamburg, Germany
        • Investigational Site, Propst-Paulsen-Straße 2
      • Hamburg, Germany
        • Investigational Site, Schweriner Straße 1
      • Haßloch, Germany
        • Investigational Site, Rathausplatz 4
      • Heidelberg, Germany
        • Investigational Site, Kurfürstenanlage 34
      • Hettstedt, Germany
        • Investigational Site, Luisenstraße 18 a
      • Hirschberg, Germany
        • Investigational Site, Hohensachsener Str. 2
      • Hofheim, Germany
        • Investigational Site, Robert-Koch-Straße 2
      • Hoyerswerda, Germany
        • Investigational Site, M.-Grollmuß-Straße 10
      • Jerichow, Germany
        • Investigational Site, J.-Lange-Straße 20, Haus 7
      • Kiel, Germany
        • Investigational Site, Goethestraße 11
      • Kiel, Germany
        • Investigational Site, Poggendörper Weg 3-9
      • Koblenz, Germany
        • Investigational Site, Markenbildchenweg 30
      • Konigstein im Taunus, Germany
        • Investigational Site, Herzog-Adolph-Straße 13
      • Kronach, Germany
        • Investigational Site, Friesener Straße 41
      • Köthen, Germany
        • Investigational Site, Schalaunische Strape 6/7
      • Lindau, Germany
        • Investigational Site, Auf dem Wall 6
      • Ludwigsfelde, Germany
        • Investigational Site, Potsdamer Straße 120A
      • Ludwigshafen, Germany
        • Investigational Site, Rheingönheimer Str. 121
      • Ludwigshafen, Germany
        • Investigational Site, Weißdornhag 2
      • Lübeck, Germany
        • Investigational Site, Königstraße 81
      • Magdeburg, Germany
        • Investigational Site, Pfeifferstraße 10
      • Mainz, Germany
        • Investigational Site, Weißliliengasse 31
      • Mannheim, Germany
        • Investigational Site, Auf dem Sand 76a
      • Merzig, Germany
        • Investigational Site, Zur Stadthalle 2
      • Merzig-Schwemmlingen, Germany
        • Investigational Site, Zum Schotzberg 1 a
      • Mönchengladbach, Germany
        • Investigational Site, Oldenkirchener Straße 43
      • München, Germany
        • Investigational Site, Irisstraße 23
      • München, Germany
        • Investigational Site, Theodolindenstraße 97
      • Münster, Germany
        • Investigational Site, Hammer Straße 95
      • Neumarkt in der Oberpfalz, Germany
        • Investigational Site, Unterer Markt 26/27
      • Nieder-Olm, Germany
        • Investigational Site, Bahnhofstraße 11
      • Nürnberg, Germany
        • Investigational Site, Glogauer Straße 42
      • Nürnberg, Germany
        • Investigational Site, Weiltinger Straße 11
      • Nürnberg, Germany
        • Investigational Site, Kleinreuther Weg 88
      • Oldenburg, Germany
        • Investigational Site, Hauptstraße 19
      • Oschatz, Germany
        • Investigational Site, Lutherstraße 22
      • Pohlheim, Germany
        • Investigational Site, Neue Mitte 6
      • Potsdam, Germany
        • Investigational Site, Großbeerenstraße 301
      • Potsdam, Germany
        • Investigational Site, R.-Breitscheid-Straße 56
      • Potsdam, Germany
        • Investigational Site, Allee nach Sanssouci 7
      • Potsdam, Germany
        • Investigational Site, Dortustraße 4
      • Recklinghausen, Germany
        • Investigational Site, Hohenzollernstraße 7
      • Roetgen, Germany
        • Investigational Site, Bundesstraße 56
      • Rostock, Germany
        • Investigational Site, St.-Petersburger Str. 18c
      • Rotenburg, Germany
        • Investigational Site, Heinz-Meise-Straße 101
      • Rottach-Egern, Germany
        • Investigational Site, Tegernseer Str. 100
      • Rottweil, Germany
        • Investigational Site, Hoerstraße 42
      • Sonnenberg, Germany
        • Investigational Site, Neustadter Straße 61
      • Stockach, Germany
        • Investigational Site, Winterspürer Straße 11
      • Strausberg, Germany
        • Investigational Site, Fichteplatz 1
      • Stuttgart, Germany
        • Investigational Site, Am Wallgraben 99
      • Stuttgart, Germany
        • Investigational Site, Industriestraße 4
      • Sundern, Germany
        • Investigational Site, Röhre 1
      • Ulm, Germany
        • Investigational Site, Olgastraße 139
      • Waltrop, Germany
        • Investigational Site, Am Stutenteich 8
      • Wiesbaden, Germany
        • Investigational Site, Langenbeckplatz 2
      • Zell, Germany
        • Investigational Site, Straße von Triptis 12

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients with Ulcerative Colitis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Prescription habits measured by daily dose of Mesalazine
Time Frame: 0 - 8 weeks
0 - 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Compliance measured by questionnaire for drug intake
Time Frame: 0 - 8 weeks
0 - 8 weeks
Quality of Life measured by EuroQol Questionnaire
Time Frame: 0 - 8 weeks
0 - 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ferring Arzneimittel GmbH

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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