Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms

GERD Clinical Trial

— C27  

Official title:

Validation of Patient-reported Outcomes Measures for the Assessment of GERD Symptoms and Their Subsequent Impact on Patients With Partial Response to Proton Pump Inhibitor (PPI) Treatment in a Two Part Multi-center Phase IIa Study Including a Four Week Randomised, Double-blind, Placebo-controlled, Parallel-group Treatment Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703534
• Other study ID #: D9120C00027
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2008
• Last updated: May 20, 2011
• Start date: May 2008
• Est. completion date: January 2009

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 478
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subject able to read and write US english and able to use electronic devices

• Subjects who have experienced GERD symptoms for at least six months

• Subjects currently taking a prescription or over-the-counter PPI medications for GERD

• Body Mass Index (BMI) 18.5-35.0, inclusive

Exclusion Criteria:

• Subjects that have not experienced any GERD symptoms improvement at all after PPI treatment

• Subjects who have any of the following conditions or diseases- Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer

• Prior surgery of the upper Gastrointestinal (GI) tract

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Acid Reflux Disease
• Gastroesophageal Reflux
• GERD
• Heartburn
• Regurgitation

Intervention

Drug:
• AZD3355
Immediate Release capsule administered as a single dose, 65mg, twice daily for 4 weeks
• Placebo
capsule. administered as a single dose twice daily for 4 weeks
• Gelusil®
Chewable tablets taken as needed

Locations

Country	Name	City	State
United States	Research Site	Akron	Ohio
United States	Research Site	Anaheim	California
United States	Research Site	Anderson	South Carolina
United States	Research Site	Arkansas City	Kansas
United States	Research Site	Asheville	North Carolina
United States	Research Site	Athens	Alabama
United States	Research Site	Atlanta	Georgia
United States	Research Site	Baltimore	Maryland
United States	Research Site	Biloxi	Mississippi
United States	Research Site	Boynton Beach	Florida
United States	Research Site	Brockton	Massachusetts
United States	Research Site	Canton	Ohio
United States	Research Site	Charlottesville	Virginia
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chesapeake	Virginia
United States	Research Site	Chesterfield	Michigan
United States	Research Site	Chevy Chase	Maryland
United States	Research Site	Chicago	Illinois
United States	Research Site	Christiansburg	Virginia
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbia	Maryland
United States	Research Site	Cranston	Rhode Island
United States	Research Site	Deland	Florida
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Elkin	North Carolina
United States	Research Site	Elkridge	Maryland
United States	Research Site	Fayetteville	North Carolina
United States	Research Site	Germantown	Tennessee
United States	Research Site	Great Neck	New York
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Harrisburg	North Carolina
United States	Research Site	Harrisburg	Pennsylvania
United States	Research Site	Hialeah	Florida
United States	Research Site	Hollywood	Maryland
United States	Research Site	Houston	Texas
United States	Research Site	Jackson	Tennessee
United States	Research Site	Jackson	Mississippi
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jefferson City	Missouri
United States	Research Site	Johnson City	Tennessee
United States	Research Site	Jupiter	Florida
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lauderdale Lakes	Florida
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Los Angeles	California
United States	Research Site	Madisonville	Kentucky
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Monroe	Louisiana
United States	Research Site	Monterey	California
United States	Research Site	Morgantown	North Carolina
United States	Research Site	Murrieta	California
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Smyrna Beach	Florida
United States	Research Site	New York	New York
United States	Research Site	Newport News	Virginia
United States	Research Site	Newton	Kansas
United States	Research Site	Norfolk	Virginia
United States	Research Site	Norman	Oklahoma
United States	Research Site	Ogden	Utah
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orange	California
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Port Orange	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	Pueblo	Colorado
United States	Research Site	Richmond	Virginia
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Sayre	Pennsylvania
United States	Research Site	Sherwood	Arkansas
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Simpsonville	South Carolina
United States	Research Site	Stockbridge	Georgia
United States	Research Site	Tampa	Florida
United States	Research Site	Torrance	California
United States	Research Site	Tucson	Arizona
United States	Research Site	Waukesha	Wisconsin
United States	Research Site	West End	Wisconsin
United States	Research Site	Wichita	Kansas
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winston-salem	North Carolina
United States	Research Site	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary	Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)	Run-in period of 8-12 days and treatment period of 26-30 days	No