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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
History of Changes

February 11, 2009
February 4, 2011
February 2009
November 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00842855 on ClinicalTrials.gov Archive Site
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Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient - a Study in France
Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patients with Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).
Gastroesophageal Reflux Disease
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1
274 GERD patients, partial responders to PPI treatment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
275
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00842855
D9120N00013
No
Debra Silberg, MD PhD, Medical Science Director, AstraZeneca R&D
AstraZeneca
i3 Innovus
Principal Investigator: Pr Stanislas Bruley des Varannes, MD PhD Institut des Maladies de l'Appareil Digestif
Study Director: Marie Sundin AstraZeneca
AstraZeneca
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP