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User Surveillance in Ulcerative Colitis (CARE)

This study has been completed.
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01363453
First received: May 30, 2011
Last updated: May 31, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition
Ulcerative Colitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acute and Remission Therapy of Ulcerative Colitis With Oral Mesalazine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Prescription habits measured by daily dose of Mesalazine [ Time Frame: 0 - 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 500
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Ulcerative Colitis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Private practices

Criteria

Inclusion Criteria:

  • therapeutic need according to SPC
  • written informed consent

Exclusion Criteria:

  • contraindications according to SPC
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01363453

  Show 105 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01363453     History of Changes
Other Study ID Numbers: FE999907
Study First Received: May 30, 2011
Last Updated: May 31, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013