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User Surveillance in Ulcerative Colitis (CARE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01363453
First Posted: June 1, 2011
Last Update Posted: June 1, 2011
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.
Collaborator:
Ferring Arzneimittel GmbH
Information provided by:
Ferring Pharmaceuticals
May 30, 2011
June 1, 2011
June 1, 2011
October 2007
May 2008   (Final data collection date for primary outcome measure)
Prescription habits measured by daily dose of Mesalazine [ Time Frame: 0 - 8 weeks ]
Same as current
No Changes Posted
  • Compliance measured by questionnaire for drug intake [ Time Frame: 0 - 8 weeks ]
  • Quality of Life measured by EuroQol Questionnaire [ Time Frame: 0 - 8 weeks ]
Same as current
Not Provided
Not Provided
 
User Surveillance in Ulcerative Colitis
Acute and Remission Therapy of Ulcerative Colitis With Oral Mesalazine
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Private practices
Ulcerative Colitis
Not Provided
Patients with Ulcerative Colitis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
July 2008
May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • therapeutic need according to SPC
  • written informed consent

Exclusion Criteria:

  • contraindications according to SPC
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01363453
FE999907
No
Not Provided
Not Provided
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
May 2011