User Surveillance in Ulcerative Colitis (CARE)
This study has been completed.
Sponsor:
Ferring Pharmaceuticals
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
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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:
Genetics Home Reference related topics:
ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
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
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
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 Colonic Diseases Digestive System Diseases |
Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on February 25, 2015