Retrospective Data Analysis in Crohn's Disease
Crohn 2
Retrospective Data Analysis of Newly Diagnosed Crohn's Disease Patients in Gastroenterological Surgeries
1 other identifier
observational
161
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2007
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 30, 2011
CompletedFirst Posted
Study publicly available on registry
June 1, 2011
CompletedJune 1, 2011
May 1, 2011
3.2 years
May 30, 2011
May 31, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Response to Mesalazine: measured by time to step up therapy
12 to 48 months
Secondary Outcomes (1)
Identification and characterisation of the responding sub-population
12 to 48 months
Study Arms (1)
Crohn's disease
Patients with initially diagnosed Crohn's disease
Eligibility Criteria
Private practices
You may qualify if:
- therapeutic need according to SPC
- written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Investigational Site, Ehrenfelsstraße 47
Berlin, Germany
Investigational Site, Möllendorfstraße 111
Berlin, Germany
Investigational Site, Graseggerstraße 105
Cologne, 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 am Main, Germany
Investigational Site, Erdbeerfeld 8
Kiel-Altenholz, Germany
Investigational Site, Hohenfelder Straße 20
Koblenz, 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
Nuremberg, Germany
Investigational Site, Marktplatz 23
Rottenburg, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 30, 2011
First Posted
June 1, 2011
Study Start
March 1, 2007
Primary Completion
May 1, 2010
Study Completion
July 1, 2010
Last Updated
June 1, 2011
Record last verified: 2011-05