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

This study has been completed.
Sponsor:
Collaborator:
i3 Innovus
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00795093
First received: November 20, 2008
Last updated: May 10, 2010
Last verified: May 2010

November 20, 2008
May 10, 2010
November 2008
January 2010   (final data collection date for primary outcome measure)
  • Quality of life, productivity loss, frequency and severity of GERD symptoms, health care resource use [ Time Frame: Collected at enrollment visit and at 3 and 6 month follow-up. (Health care resource use is at enrollment visit collected retrospectively 6 months) ] [ Designated as safety issue: No ]
  • Utility values [ Time Frame: Collected at enrollment visit and at 6 month follow-up. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00795093 on ClinicalTrials.gov Archive Site
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Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US
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
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Probability Sample

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

Gastroesophageal Reflux Disease (GERD)
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1
552 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
552
January 2010
January 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 a consecutive 4 week period
  • Remaining GERD symptoms despite optimized PPI treatment
  • Able to read and write in US English, 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00795093
D9120N00005
No
Debra Silberg, MD PhD, Medical Science Director, Clinical Research, AstraZeneca R&D
AstraZeneca
i3 Innovus
Principal Investigator: Meg Good i3 Innovus
Study Director: Marie Sundin AstraZeneca
AstraZeneca
May 2010

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