User Surveillance in Ulcerative Colitis

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational , Karlsplatz 18, Aalen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

therapeutic need according to SPC
written informed consent

Exclusion criteria

contraindications according to SPC

Treatment and study plan

Primary outcomes

Prescription habits measured by daily dose of Mesalazine

Time frame: 0 - 8 weeks

Secondary outcomes

Compliance measured by questionnaire for drug intake

Time frame: 0 - 8 weeks
Quality of Life measured by EuroQol Questionnaire

Time frame: 0 - 8 weeks

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Collaborators

Ferring Arzneimittel GmbH

Registry information

Official study title

Acute and Remission Therapy of Ulcerative Colitis With Oral Mesalazine

Acronym: CARE

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jun 1, 2011
Registry last updated: Jun 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed