User Surveillance in Ulcerative Colitis

Acute and Remission Therapy of Ulcerative Colitis With Oral Mesalazine

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01363453

Acronym

CARE

Enrollment

500

Registered

2011-06-01

Start date

2007-10-31

Completion date

2008-07-31

Last updated

2011-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* therapeutic need according to SPC * written informed consent

Exclusion criteria

* contraindications according to SPC

Design outcomes

Primary

Measure	Time frame
Prescription habits measured by daily dose of Mesalazine	0 - 8 weeks

Secondary

Measure	Time frame
Compliance measured by questionnaire for drug intake	0 - 8 weeks
Quality of Life measured by EuroQol Questionnaire	0 - 8 weeks

Countries

Germany

Outcome results