Clinical trial NCT00842855: Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient - a Study in France
Official title: Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
PPI
partial responders
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: i3 Innovus
First posted: 2009-02-12
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).

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.


Eligibility 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

Primary outcomes:
measure: Productivity loss; Frequency and severity of GERD symptoms; Health care resource use
timeFrame: 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)
measure: Utility values; Quality of Life
timeFrame: Collected at enrollment visit and at 6 and 12 month follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Bandol
country: France
facility: Research Site
city: Beaumont sur Oise
country: France
facility: Research Site
city: Beausoleil
country: France
facility: Research Site
city: Behren Les Forbach
country: France
facility: Research Site
city: Berck-sur-mer
country: France
facility: Research Site
city: Bievres
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Bressuire
country: France
facility: Research Site
city: Brest
country: France
facility: Research Site
city: Cambrai
country: France
facility: Research Site
city: Chalon sur Saone
country: France
facility: Research Site
city: Colmar
country: France
facility: Research Site
city: Cornebarrieu
country: France
facility: Research Site
city: Creil
country: France
facility: Research Site
city: Creteil
country: France
facility: Research Site
city: Dieppe
country: France
facility: Research Site
city: Freyming Merlebach
country: France
facility: Research Site
city: Gien
country: France
facility: Research Site
city: Hagondange
country: France
facility: Research Site
city: Ivoy Le Pre
country: France
facility: Research Site
city: La Garde
country: France
facility: Research Site
city: La Rochelle
country: France
facility: Research Site
city: La Seyne sur Mer
country: France
facility: Research Site
city: Le Lavandou
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Mont-de-Marsan
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Saint-mandrier
country: France
facility: Research Site
city: SANARY-sur-Mer
country: France
facility: Research Site
city: Sanary
country: France
facility: Research Site
city: Six Fours les plages
country: France
facility: Research Site
city: Six-fours
country: France
facility: Research Site
city: St Cyr sur Mer
country: France
facility: Research Site
city: St Jeannet
country: France
facility: Research Site
city: St Mande
country: France
facility: Research Site
city: Stiring Wendel
country: France
facility: Research Site
city: Toulon
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Toussieu
country: France
facility: Research Site
city: Venerque
country: France
facility: Research Site
city: Verdun
country: France
facility: Research Site
city: Versailles
country: France
facility: Research Site
city: Witry les Reims
country: France
facility: Research Site
Study officials:
affiliation: Institut des Maladies de l'Appareil digestif
name: Pr Stanislas Bruley des Varannes, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Marie Sundin
role: STUDY_DIRECTOR
References: