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User Surveillance in Ulcerative Colitis (CARE)

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ClinicalTrials.gov Identifier: NCT01363453
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : June 1, 2011
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by:
Ferring Pharmaceuticals

Study Description
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Brief Summary:
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 or disease
Ulcerative Colitis

Study Design
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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acute and Remission Therapy of Ulcerative Colitis With Oral Mesalazine
Study Start Date : October 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
Patients with Ulcerative Colitis


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


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Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01363453     History of Changes
Other Study ID Numbers: FE999907
First Posted: June 1, 2011    Key Record Dates
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