Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US
REMAIN
Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient
1 other identifier
observational
552
1 country
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2008
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 20, 2008
CompletedFirst Posted
Study publicly available on registry
November 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedMay 11, 2010
May 1, 2010
1.2 years
November 20, 2008
May 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Quality of life, productivity loss, frequency and severity of GERD symptoms, health care resource use
Collected at enrollment visit and at 3 and 6 month follow-up. (Health care resource use is at enrollment visit collected retrospectively 6 months)
Utility values
Collected at enrollment visit and at 6 month follow-up.
Study Arms (1)
1
552 GERD patients, partial responders to PPI treatment
Eligibility Criteria
Patients with Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- i3 Innovuscollaborator
Study Sites (53)
Research Site
Leeds, Alabama, United States
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Pheonix, Arizona, United States
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Tucson, Arizona, United States
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Concord, California, United States
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Lancaster, California, United States
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Los Banos, California, United States
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Solana Beach, California, United States
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Newark, Delaware, United States
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Altamonte Springs, Florida, United States
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Cocoa, Florida, United States
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DeFuniak Springs, Florida, United States
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Largo, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Peonia, Florida, United States
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Tampa, Florida, United States
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Columbus, Georgia, United States
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Roswell, Georgia, United States
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Royston, Georgia, United States
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Snellville, Georgia, United States
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Belleville, Illinois, United States
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Mishawaka, Indiana, United States
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Metaire, Louisiana, United States
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Prince Frederick, Maryland, United States
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Towson, Maryland, United States
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Florissant, Missouri, United States
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Jefferson City, Missouri, United States
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Atco, New Jersey, United States
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Fair Lawn, New Jersey, United States
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Cary, North Carolina, United States
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Elkin, North Carolina, United States
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New Bern, North Carolina, United States
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Stanley, North Carolina, United States
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Statesville, North Carolina, United States
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Beachwood, Ohio, United States
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Dayton, Ohio, United States
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Vandalia, Ohio, United States
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Aliquippa, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Charleston, South Carolina, United States
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Athens, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Irving, Texas, United States
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San Antonio, Texas, United States
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San Marcos, Texas, United States
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Southlake, Texas, United States
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West Jordan, Utah, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meg Good
i3 Innovus
- STUDY DIRECTOR
Marie Sundin
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 20, 2008
First Posted
November 21, 2008
Study Start
November 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
May 11, 2010
Record last verified: 2010-05