- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02368743
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
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
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Vandoeuvre-les-Nancy, France
- Gastro-Entérologie et Hépatologie - CHU Brabois (there may be other sites in this country)
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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 |
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mesalazine
Treatment according to standard clinical practice.
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Other Names:
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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
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From baseline to week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Rectal Diseases
- Proctitis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Mesalamine
Other Study ID Numbers
- 000179
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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