User Surveillance in Ulcerative Colitis

Completed

• Conditions: Ulcerative Colitis

• Registration Number: NCT01363453
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-05
• Study Completion: 2008-07
• Status Verified: 2011-05
• Study First Submitted: 2011-05-30
• Study First Submitted QC: 2011-05-31
• Last Update Submitted: 2011-05-31
• Study First Posted: 2011-06-01
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• therapeutic need according to SPC
• written informed consent

Exclusion Criteria

• contraindications according to SPC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prescription habits measured by daily dose of Mesalazine	0 - 8 weeks

Secondary Outcome Measures

Name	Time	Method
Compliance measured by questionnaire for drug intake	0 - 8 weeks
Quality of Life measured by EuroQol Questionnaire	0 - 8 weeks

Trial Locations

Locations (105)

Investigational , Karlsplatz 18; 🇩🇪 Aalen, Germany

Investigational Site, Goethestraße 5; 🇩🇪 Ansbach, Germany

Investigational Site, Elisenstraße 32; 🇩🇪 Aschaffenburg, Germany

Investigational Site, Haingasse 22; 🇩🇪 Bad Homburg, Germany

Investigational Site, Blankenburger Chaussee 86; 🇩🇪 Berlin, Germany

Investigational Site, Etkar-André-Straße 8; 🇩🇪 Berlin, Germany

Investigational Site, Karl-Marx-Straße 46; 🇩🇪 Berlin, Germany

Investigational Site, Martin-Luther-Straße 134; 🇩🇪 Berlin, Germany

Investigational Site, Mohrenstraße 6; 🇩🇪 Berlin, Germany

Investigational Site, Myslowitzer Straße 49; 🇩🇪 Berlin, Germany

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