Clinical trial NCT00795093: Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US
Official title: Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: GERD
PPI
partial responders
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: i3 Innovus
First posted: 2008-11-21
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Gastroesophageal Reflux Disease (GERD) classified as partial responders to proton pump inhibitors (PPIs).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of life, productivity loss, frequency and severity of GERD symptoms, health care resource use
timeFrame: Collected at enrollment visit and at 3 and 6 month follow-up. (Health care resource use is at enrollment visit collected retrospectively 6 months)
measure: Utility values
timeFrame: Collected at enrollment visit and at 6 month follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United States
facility: Research Site
state: Alabama
city: Pheonix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Concord
country: United States
facility: Research Site
state: California
city: Lancaster
country: United States
facility: Research Site
state: California
city: Los Banos
country: United States
facility: Research Site
state: California
city: Solana Beach
country: United States
facility: Research Site
state: California
city: Newark
country: United States
facility: Research Site
state: Delaware
city: Altamonte Springs
country: United States
facility: Research Site
state: Florida
city: Cocoa
country: United States
facility: Research Site
state: Florida
city: Defuniak Springs
country: United States
facility: Research Site
state: Florida
city: Largo
country: United States
facility: Research Site
state: Florida
city: Maitland
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Naples
country: United States
facility: Research Site
state: Florida
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Palm Harbor
country: United States
facility: Research Site
state: Florida
city: Peonia
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Columbus
country: United States
facility: Research Site
state: Georgia
city: Roswell
country: United States
facility: Research Site
state: Georgia
city: Royston
country: United States
facility: Research Site
state: Georgia
city: Snellville
country: United States
facility: Research Site
state: Georgia
city: Belleville
country: United States
facility: Research Site
state: Illinois
city: Mishawaka
country: United States
facility: Research Site
state: Indiana
city: Metaire
country: United States
facility: Research Site
state: Louisiana
city: Prince Frederick
country: United States
facility: Research Site
state: Maryland
city: Towson
country: United States
facility: Research Site
state: Maryland
city: Florissant
country: United States
facility: Research Site
state: Missouri
city: Jefferson City
country: United States
facility: Research Site
state: Missouri
city: Atco
country: United States
facility: Research Site
state: New Jersey
city: Fair Lawn
country: United States
facility: Research Site
state: New Jersey
city: Cary
country: United States
facility: Research Site
state: North Carolina
city: Elkin
country: United States
facility: Research Site
state: North Carolina
city: New Bern
country: United States
facility: Research Site
state: North Carolina
city: Stanley
country: United States
facility: Research Site
state: North Carolina
city: Statesville
country: United States
facility: Research Site
state: North Carolina
city: Beachwood
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Vandalia
country: United States
facility: Research Site
state: Ohio
city: Aliquippa
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Warwick
country: United States
facility: Research Site
state: Rhode Island
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Athens
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Irving
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Marcos
country: United States
facility: Research Site
state: Texas
city: Southlake
country: United States
facility: Research Site
state: Texas
city: West Jordan
country: United States
facility: Research Site
state: Utah
Study officials:
affiliation: i3 Innovus
name: Meg Good
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Marie Sundin
role: STUDY_DIRECTOR
References: