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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00703534
Other study ID # D9120C00027
Secondary ID
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)


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
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