Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient - a Study in France

NCT ID: NCT00842855

Last Updated: 2011-02-07

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

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Recruitment Status

COMPLETED

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

274 GERD patients, partial responders to PPI treatment

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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i3 Innovus

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D

Principal Investigators

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Pr Stanislas Bruley des Varannes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institut des Maladies de l'Appareil digestif

Marie Sundin

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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

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Countries

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France

Other Identifiers

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D9120N00013

Identifier Type: -

Identifier Source: org_study_id

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