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

This study has been completed.
Sponsor:
Collaborator:
i3 Innovus
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00842855
First received: February 11, 2009
Last updated: February 4, 2011
Last verified: February 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Research Site
Bandol, France
Research Site
Beaumont sur Oise, France
Research Site
Beausoleil, France
Research Site
Behren Les Forbach, France
Research Site
Berck-sur-mer, France
Research Site
Bievres, France
Research Site
Bordeaux, France
Research Site
Bressuire, France
Research Site
Brest, France
Research Site
Cambrai, France
Research Site
Chalon sur Saone, France
Research Site
Colmar, France
Research Site
Cornebarrieu, France
Research Site
Creil, France
Research Site
Creteil, France
Research Site
Dieppe, France
Research Site
Freyming Merlebach, France
Research Site
Gien, France
Research Site
Hagondange, France
Research Site
Ivoy Le Pre, France
Research Site
La Garde, France
Research Site
La Rochelle, France
Research Site
La Seyne sur Mer, France
Research Site
Le Lavandou, France
Research Site
Lyon, France
Research Site
Marseille, France
Research Site
Mont-de-Marsan, France
Research Site
Nice, France
Research Site
Paris, France
Research Site
Rouen, France
Research Site
Saint-mandrier, France
Research Site
Sanary, France
Research Site
SANARY-sur-Mer, France
Research Site
Six Fours les plages, France
Research Site
Six-fours, France
Research Site
St Cyr sur Mer, France
Research Site
St Jeannet, France
Research Site
St Mande, France
Research Site
Stiring Wendel, France
Research Site
Toulon, France
Research Site
Toulouse, France
Research Site
Toussieu, France
Research Site
Venerque, France
Research Site
Verdun, France
Research Site
Versailles, France
Research Site
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 August 20, 2014