Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

User Surveillance in Ulcerative Colitis (CARE)

This study has been completed.
Ferring Arzneimittel GmbH
Information provided by:
Ferring Pharmaceuticals Identifier:
First received: May 30, 2011
Last updated: May 31, 2011
Last verified: May 2011

May 30, 2011
May 31, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01363453 on Archive Site
  • Compliance measured by questionnaire for drug intake [ Time Frame: 0 - 8 weeks ] [ Designated as safety issue: No ]
  • Quality of Life measured by EuroQol Questionnaire [ Time Frame: 0 - 8 weeks ] [ Designated as safety issue: No ]
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 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 Identifier (NCT Number) in Medline.
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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP