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

Sponsor:	AstraZeneca
Collaborator:	i3 Innovus
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00842855

Purpose

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.

Condition
Gastroesophageal Reflux Disease

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient

Resource links provided by NLM:

MedlinePlus related topics: GERD

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]
Utility values; Quality of Life [ Time Frame: Collected at enrollment visit and at 6 and 12 month follow-up. ] [ Designated as safety issue: No ]

Estimated Enrollment:	275
Study Start Date:	February 2009
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 274 GERD patients, partial responders to PPI treatment

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842855

Locations

France
Research Site
Bandol, France
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Beaumont sur Oise, France
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Beausoleil, France
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Behren Les Forbach, France
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Berck-sur-mer, France
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Bievres, 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 Saone, France
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Colmar, France
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Cornebarrieu, France
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Creil, France
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Creteil, 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 Pre, 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-mandrier, France
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Sanary, France
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SANARY-sur-Mer, France
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Six Fours les plages, France
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Six-fours, France
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St Cyr sur Mer, France
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St Jeannet, France
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St Mande, 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 les Reims, France

Sponsors and Collaborators

AstraZeneca

i3 Innovus

Investigators

Principal Investigator:	Pr Stanislas Bruley des Varannes, MD PhD	Institut des Maladies de l'Appareil Digestif
Study Director:	Marie Sundin	AstraZeneca

More Information

No publications provided

Responsible Party:	Debra Silberg, MD PhD, Medical Science Director, AstraZeneca R&D
ClinicalTrials.gov Identifier:	NCT00842855 History of Changes
Other Study ID Numbers:	D9120N00013
Study First Received:	February 11, 2009
Last Updated:	February 4, 2011
Health Authority:	France: French Data Protection Authority

Keywords provided by AstraZeneca:

GERD
PPI
partial responders

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders

Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 09, 2012