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OpenTrials
Completed

NCT Number: NCT02368743

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastro-Entérologie et Hépatologie - CHU Brabois (there may be other sites in this country)

Vandœuvre-lès-Nancy, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Mesalazine

Drug

Other names: Pentasa®

Primary outcomes

  1. Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score

    Time frame: From baseline to week 8

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Acronym: QUARTZ

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Feb 23, 2015
Registry last updated
Jul 5, 2018

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.