QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®) (QUARTZ)

July 3, 2018 updated by: Ferring Pharmaceuticals
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 proctitis or distal proctosigmoiditis. This study should be able to provide data on patients' health related quality of life, compliance and efficacy in real clinical practice

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Vandoeuvre-les-Nancy, France
        • Gastro-Entérologie et Hépatologie - CHU Brabois (there may be other sites in this country)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Gastroenterologists with private and/or hospital practice

Description

Inclusion Criteria:

  • Patient aged 18 years or older.
  • Patient suffering from mild to moderate active proctitis or distal proctosigmoiditis (MAYO score ≥ 3 and ≤ 10) at inclusion based on clinical and endoscopic findings within 6 months before study inclusion.
  • Patient with evidence of endoscopic active proctitis or distal proctosigmoiditis (Montreal classification E1 or E2 defined by an involvement not exceeding 25 cm from the anal margin) within 6 months before study inclusion.
  • Treatment of the current flare with Pentasa® to induce a remission initiated by the patient, the general practitioner or the gastroenterologist, during the inclusion visit or during the week before the inclusion visit.
  • 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 or distal proctosigmoiditis.
  • Patient with left sided, colitis 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mesalazine
Treatment according to standard clinical practice.
Other Names:
  • Pentasa®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score
Time Frame: From baseline to week 8
From baseline to week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

January 2, 2018

Study Registration Dates

First Submitted

February 16, 2015

First Submitted That Met QC Criteria

February 16, 2015

First Posted (Estimate)

February 23, 2015

Study Record Updates

Last Update Posted (Actual)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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