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Retrospective Data Analysis in Crohn's Disease (Crohn 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01363427
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : June 1, 2011
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Brief Summary:
The purpose of this study is to identify prognostic parameters about efficacy of Mesalazine in recently diagnosed patients with Morbus Crohn by retrospective data collection.

Condition or disease
Crohn's Disease

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Study Type : Observational
Actual Enrollment : 161 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Data Analysis of Newly Diagnosed Crohn's Disease Patients in Gastroenterological Surgeries
Study Start Date : March 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort
Crohn's disease
Patients with initially diagnosed Crohn's disease



Primary Outcome Measures :
  1. Response to Mesalazine: measured by time to step up therapy [ Time Frame: 12 to 48 months ]

Secondary Outcome Measures :
  1. Identification and characterisation of the responding sub-population [ Time Frame: 12 to 48 months ]
    measured by: (a) Age at diagnosis, (b) Proportion of patients with minor endoscopic lesions, (c) Lack of severe mucosal lesions (Adapted Rutgeerts Score < 2)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Private practices
Criteria

Inclusion Criteria:

  • therapeutic need according to SPC
  • written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363427


Locations
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Germany
Investigational Site, Ehrenfelsstraße 47
Berlin, Germany
Investigational Site, Möllendorfstraße 111
Berlin, Germany
Investigational Site, Münchner Straße 64
Dachau, Germany
Investigational Site, Karlsbader Straße 7
Dinkelsbühl, Germany
Investigational Site, Heiligengrabstraße 16
Hof, Germany
Investigational Site, Am Tiefen Weg 2
Karlstadt, Germany
Investigational Site, Erdbeerfeld 8
Kiel-Altenholz, Germany
Investigational Site, Hohenfelder Straße 20
Koblenz, Germany
Investigational Site, Graseggerstraße 105
Köln, Germany
Investigational Site, Funkenburgstraße 19
Leipzig, Germany
Investigational Site, Franz-Kail-Straße 2
Leverkusen, Germany
Investigational Site, Bahnhofplatz 2
Mainz, Germany
Investigational Site, Uferstraße 3
Minden, Germany
Investigational Site, Hammer Straße 95
Münster, Germany
Investigational Site, Weiltinger Str. 11
Nürnberg, Germany
Investigational Site, Marktplatz 23
Rottenburg, Germany
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Clinical Development Support Ferring Pharmaceuticals
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Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01363427    
Other Study ID Numbers: FE 999907 (Pentasa)
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases