Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient - a Study in France (REMAIN)
February 4, 2011 updated by: AstraZeneca
Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient
The purpose of this study is to describe common treatment pathways, to collect health care utilization data and to assess symptom load as well as impact of symptoms on daily life in GERD patients who are partial-responders to PPI treatment.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
275
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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Bandol, France
- Research Site
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Beaumont sur Oise, France
- Research Site
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Beausoleil, France
- Research Site
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Behren Les Forbach, France
- Research Site
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Berck-sur-mer, France
- Research Site
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Bievres, France
- Research Site
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Bordeaux, France
- Research Site
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Bressuire, France
- Research Site
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Brest, France
- Research Site
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Cambrai, France
- Research Site
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Chalon sur Saone, France
- Research Site
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Colmar, France
- Research Site
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Cornebarrieu, France
- Research Site
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Creil, France
- Research Site
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Creteil, France
- Research Site
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Dieppe, France
- Research Site
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Freyming Merlebach, France
- Research Site
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Gien, France
- Research Site
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Hagondange, France
- Research Site
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Ivoy Le Pre, France
- Research Site
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La Garde, France
- Research Site
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La Rochelle, France
- Research Site
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La Seyne sur Mer, France
- Research Site
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Le Lavandou, France
- Research Site
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Lyon, France
- Research Site
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Marseille, France
- Research Site
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Mont-de-Marsan, France
- Research Site
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Nice, France
- Research Site
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Paris, France
- Research Site
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Rouen, France
- Research Site
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SANARY-sur-Mer, France
- Research Site
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Saint-mandrier, France
- Research Site
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Sanary, France
- Research Site
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Six Fours les plages, France
- Research Site
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Six-fours, France
- Research Site
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St Cyr sur Mer, France
- Research Site
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St Jeannet, France
- Research Site
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St Mande, France
- Research Site
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Stiring Wendel, France
- Research Site
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Toulon, France
- Research Site
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Toulouse, France
- Research Site
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Toussieu, France
- Research Site
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Venerque, France
- Research Site
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Verdun, France
- Research Site
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Versailles, France
- Research Site
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Witry les Reims, France
- Research Site
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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
Probability Sample
Study Population
Patients with Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).
Description
Inclusion Criteria:
- At least 6 month history of GERD symptoms
- Treated with unchanged optimized PPI treatment for any GERD indication during the last 4 weeks before enrollment
- Remaining GERD symptoms despite optimized PPI treatment
- Able to read and write in French, and able to comply with study requirements
Exclusion Criteria:
- Patients that have not experienced any GERD symptom improvement at all during PPI treatment
- Involvement in the planning or conduct of the study
- Involvement in any other observational study or in any clinical study at the time of this study or during the last 6 months
- Prior surgery of the upper GI tract
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
Cohorts and Interventions
Group / Cohort |
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1
274 GERD patients, partial responders to PPI treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Productivity loss; Frequency and severity of GERD symptoms; Health care resource use
Time Frame: Collected at enrollment visit and at 3, 6, 9 and 12 month follow-up. (Health care resource use is collected by the physician at enrollment visit and 6 and 12 month follow-up)
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Collected at enrollment visit and at 3, 6, 9 and 12 month follow-up. (Health care resource use is collected by the physician at enrollment visit and 6 and 12 month follow-up)
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Utility values; Quality of Life
Time Frame: Collected at enrollment visit and at 6 and 12 month follow-up.
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Collected at enrollment visit and at 6 and 12 month follow-up.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pr Stanislas Bruley des Varannes, MD PhD, Institut des Maladies de l'Appareil digestif
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
February 1, 2009
Primary Completion (ACTUAL)
November 1, 2010
Study Completion (ACTUAL)
November 1, 2010
Study Registration Dates
First Submitted
February 11, 2009
First Submitted That Met QC Criteria
February 11, 2009
First Posted (ESTIMATE)
February 12, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
February 7, 2011
Last Update Submitted That Met QC Criteria
February 4, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D9120N00013
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.