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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-01-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

NCT00209300

Ulcerative Colitis

COMPLETED PHASE3

Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment

NCT02261636

Ulcerative Colitis

COMPLETED

Mesalazine (PENTASA®) in Ulcerative Colitis

NCT01517607

Ulcerative Colitis

COMPLETED

An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase

NCT02368717

Ulcerative Colitis

COMPLETED PHASE3

A Study With Pentasa in Patients With Active Crohn's Disease

NCT00862121

Crohn´s Disease

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Distal Ulcerative Colitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

mesalazine

Treatment according to standard clinical practice.

mesalazine

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mesalazine

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pentasa®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No