Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient - a Study in France
REMAIN
1 other identifier
observational
275
1 country
44
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2009
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 11, 2009
CompletedFirst Posted
Study publicly available on registry
February 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFebruary 7, 2011
February 1, 2011
1.7 years
February 11, 2009
February 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Productivity loss; Frequency and severity of GERD symptoms; Health care resource use
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)
Utility values; Quality of Life
Collected at enrollment visit and at 6 and 12 month follow-up.
Study Arms (1)
1
274 GERD patients, partial responders to PPI treatment
Eligibility Criteria
Patients with Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- i3 Innovuscollaborator
Study Sites (44)
Research Site
Bandol, France
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Beaumont-sur-Oise, France
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Beausoleil, France
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Behren-lès-Forbach, France
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Berck, France
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Bièvres, France
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Bordeaux, France
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Bressuire, France
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Brest, France
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Cambrai, France
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Chalon-sur-Saône, France
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Colmar, France
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Cornebarrieu, France
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Creil, France
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Créteil, France
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Dieppe, France
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Freyming-Merlebach, France
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Gien, France
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Hagondange, France
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Ivoy-le-Pré, France
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La Garde, France
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La Rochelle, France
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La Seyne-sur-Mer, France
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Le Lavandou, France
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Lyon, France
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Marseille, France
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Mont-de-Marsan, France
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Nice, France
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Paris, France
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Rouen, France
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Saint-Cyr-sur-Mer, France
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Saint-Jeannet, France
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Saint-Mandé, France
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Saint-Mandrier-sur-Mer, France
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Sanary-sur-Mer, France
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Six-Fours-les-Plages, France
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Stiring-Wendel, France
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Toulon, France
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Toulouse, France
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Toussieu, France
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Venerque, France
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Verdun, France
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Versailles, France
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Witry-lès-Reims, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pr Stanislas Bruley des Varannes, MD PhD
Institut des Maladies de l'Appareil digestif
- STUDY DIRECTOR
Marie Sundin
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 11, 2009
First Posted
February 12, 2009
Study Start
February 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
February 7, 2011
Record last verified: 2011-02