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NCT01363427 Clinical Trial

Retrospective Data Analysis in Crohn's Disease

Crohn's Disease Clinical Trial

— Crohn 2  

Official title:
Retrospective Data Analysis of Newly Diagnosed Crohn's Disease Patients in Gastroenterological Surgeries

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01363427
Other study ID # FE 999907 (Pentasa)
Secondary ID
Status Completed
Phase N/A
First received May 30, 2011
Last updated May 31, 2011
Start date March 2007
Est. completion date July 2010

Study information
Verified date May 2011
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 161
Est. completion date July 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- therapeutic need according to SPC

- written informed consent

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
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

Sponsors (1)
Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response to Mesalazine: measured by time to step up therapy 12 to 48 months No
Secondary Identification and characterisation of the responding sub-population measured by: (a) Age at diagnosis, (b) Proportion of patients with minor endoscopic lesions, (c) Lack of severe mucosal lesions (Adapted Rutgeerts Score < 2) 12 to 48 months No
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