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Crohn 2: Retrospective Data Analysis in Crohn's Disease

Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01363427
Collaborator
(none)
161
Enrollment
16
Locations
40
Duration (Months)
10.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Mar 1, 2007
    Actual Primary Completion Date :
    May 1, 2010
    Actual Study Completion Date :
    Jul 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Crohn's disease

    Patients with initially diagnosed Crohn's disease

    Outcome Measures

    Primary Outcome Measures

    1. Response to Mesalazine: measured by time to step up therapy [12 to 48 months]

    Secondary Outcome Measures

    1. Identification and characterisation of the responding sub-population [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • therapeutic need according to SPC

    • written informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site, Ehrenfelsstraße 47 Berlin Germany
    2 Investigational Site, Möllendorfstraße 111 Berlin Germany
    3 Investigational Site, Münchner Straße 64 Dachau Germany
    4 Investigational Site, Karlsbader Straße 7 Dinkelsbühl Germany
    5 Investigational Site, Heiligengrabstraße 16 Hof Germany
    6 Investigational Site, Am Tiefen Weg 2 Karlstadt Germany
    7 Investigational Site, Erdbeerfeld 8 Kiel-Altenholz Germany
    8 Investigational Site, Hohenfelder Straße 20 Koblenz Germany
    9 Investigational Site, Graseggerstraße 105 Köln Germany
    10 Investigational Site, Funkenburgstraße 19 Leipzig Germany
    11 Investigational Site, Franz-Kail-Straße 2 Leverkusen Germany
    12 Investigational Site, Bahnhofplatz 2 Mainz Germany
    13 Investigational Site, Uferstraße 3 Minden Germany
    14 Investigational Site, Hammer Straße 95 Münster Germany
    15 Investigational Site, Weiltinger Str. 11 Nürnberg Germany
    16 Investigational Site, Marktplatz 23 Rottenburg Germany

    Sponsors and Collaborators

    • Ferring Pharmaceuticals

    Investigators

    • Study Director: Clinical Development Support, Ferring Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01363427
    Other Study ID Numbers:
    • FE 999907 (Pentasa)
    First Posted:
    Jun 1, 2011
    Last Update Posted:
    Jun 1, 2011
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Crohn Disease

    Study Results

    No Results Posted as of Jun 1, 2011