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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
  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:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Prescription habits measured by daily dose of Mesalazine [ Time Frame: 0 - 8 weeks ]

Secondary Outcome Measures:
  • Compliance measured by questionnaire for drug intake [ Time Frame: 0 - 8 weeks ]
  • Quality of Life measured by EuroQol Questionnaire [ Time Frame: 0 - 8 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363453


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

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01363453     History of Changes
Other Study ID Numbers: FE999907
First Submitted: May 30, 2011
First Posted: June 1, 2011
Last Update Posted: June 1, 2011
Last Verified: May 2011

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