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

NCT ID: NCT00795093

Last Updated: 2010-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

552 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease (GERD)

Study Design

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Observational Model Type

COHORT

Study Groups

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1

552 GERD patients, partial responders to PPI treatment

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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i3 Innovus

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D

Principal Investigators

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Meg Good

Role: PRINCIPAL_INVESTIGATOR

i3 Innovus

Marie Sundin

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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

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Countries

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United States

Other Identifiers

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D9120N00005

Identifier Type: -

Identifier Source: org_study_id

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