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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00795093
Other study ID # D9120N00005
Secondary ID
Status Completed
Phase N/A
First received November 20, 2008
Last updated May 10, 2010
Start date November 2008
Est. completion date January 2010

Study information

Verified date May 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 552
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort


Locations

Country Name City State
United States Research Site Aliquippa Pennsylvania
United States Research Site Altamonte Springs Florida
United States Research Site Atco New Jersey
United States Research Site Athens Tennessee
United States Research Site Austin Texas
United States Research Site Beachwood Ohio
United States Research Site Belleville Illinois
United States Research Site Cary North Carolina
United States Research Site Charleston South Carolina
United States Research Site Cocoa Florida
United States Research Site Columbus Georgia
United States Research Site Concord California
United States Research Site Dallas Texas
United States Research Site Dayton Ohio
United States Research Site Defuniak Springs Florida
United States Research Site Elkin North Carolina
United States Research Site Fair Lawn New Jersey
United States Research Site Florissant Missouri
United States Research Site Irving Texas
United States Research Site Jefferson City Missouri
United States Research Site Lancaster California
United States Research Site Largo Florida
United States Research Site Leeds Alabama
United States Research Site Los Banos California
United States Research Site Maitland Florida
United States Research Site Metaire Louisiana
United States Research Site Miami Florida
United States Research Site Mishawaka Indiana
United States Research Site Naples Florida
United States Research Site New Bern North Carolina
United States Research Site Newark Delaware
United States Research Site Ocala Florida
United States Research Site Orlando Florida
United States Research Site Palm Harbor Florida
United States Research Site Peonia Florida
United States Research Site Pheonix Arizona
United States Research Site Philadelphia Pennsylvania
United States Research Site Prince Frederick Maryland
United States Research Site Roswell Georgia
United States Research Site Royston Georgia
United States Research Site San Antonio Texas
United States Research Site San Marcos Texas
United States Research Site Snellville Georgia
United States Research Site Solana Beach California
United States Research Site Southlake Texas
United States Research Site Stanley North Carolina
United States Research Site Statesville North Carolina
United States Research Site Tampa Florida
United States Research Site Towson Maryland
United States Research Site Tucson Arizona
United States Research Site Vandalia Ohio
United States Research Site Warwick Rhode Island
United States Research Site West Jordan Utah

Sponsors (2)

Lead Sponsor Collaborator
AstraZeneca i3 Innovus

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Primary Utility values Collected at enrollment visit and at 6 month follow-up. No
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