GERD Clinical Trial
— C27Official 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
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).
| 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| 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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