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

Gastroesophageal Reflux Disease (GERD) Clinical Trial

— REMAIN  

Official title:

Partial Response to PPI Treatment: The Cost to Society and the Burden to the Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795093
• Other study ID #: D9120N00005
• 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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

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