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

Distal Ulcerative Colitis Clinical Trial

— QUARTZ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368743
• Other study ID #: 000179
• Status: Completed
• Start date: December 2015
• Est. completion date: January 2, 2018

Study information

• Verified date: July 2018
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: January 2, 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Distal Ulcerative Colitis
• Proctitis

Intervention

Drug:
• mesalazine

Locations

Country	Name	City	State
France	Gastro-Entérologie et Hépatologie - CHU Brabois (there may be other sites in this country)	Vandoeuvre-les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) total score		From baseline to week 8