QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)
Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Active Ulcerative Proctitis
Intervention: mesalazine (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s): Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals
Overall contact: Clinical Development Support, Email: DK0-Disclosure@ferring.com
Summary
This national, observational and multicentre study aims at establishing a picture of real
clinical practices management among patients treated with Pentasa®, according to the current
therapeutic strategy in ulcerative proctitis. This study should be able to provide data on
patients' health related quality of life, compliance and efficacy in real clinical practice.
Clinical Details
Official title: QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®)
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient aged 18 years or older.
- Patient suffering from mild to moderate active proctitis (MAYO score ≥ 3 and ≤ 10) at
inclusion based on clinical and endoscopic findings within one month before study
inclusion
- Patient with evidence of endoscopic active proctitis (Montreal classification E1
defined by an involvement limited to the rectum that is, proximal extent of
inflammation is distal to the rectosigmoid junction) within one month before study
inclusion.
- Patient for whom the investigator has decided to start during the inclusion visit a
treatment of the current flare with Pentasa® to induce a remission.
- Patient having received oral and written information on the study, without any
objections for the use of his/her personal data, and having signed a written Informed
Consent Form.
Exclusion Criteria:
- Patient included in an interventional study assessing treatment for active proctitis
- Patient with left sided, sigmoiditis or pancolitis.
- Patient with severe proctitis (MAYO score ≥ 11 at inclusion).
- Patient previously treated with biologics.
- Patient treated with immunosuppressive within 1 month before study inclusion.
- Patient treated with corticosteroids within 2 weeks before study inclusion.
Locations and Contacts
Clinical Development Support, Email: DK0-Disclosure@ferring.com
Gastro-Entérologie et Hépatologie - CHU Brabois (there may be other sites in this country), Vandoeuvre-les-Nancy, France; Not yet recruiting
Additional Information
Starting date: September 2015
Last updated: April 27, 2015
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