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
  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 ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014