Status:
COMPLETED
Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US
Lead Sponsor:
AstraZeneca
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The purpose of this research study is to compare the safety and effectiveness (how well the medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any medication) tak...
Eligibility Criteria
Inclusion
- Prior to the run-in period, a history of heartburn or acid regurgitation for 3 months or longer or any history of EE;
- Prior to the run-in period, nighttime heartburn averaging at least 2 or 3 times per week;
- Prior to the run-in period, a history of sleep disturbances associated with GERD for 1 month or more;
Exclusion
- Any condition other than GERD that is either the primary cause of, or a significant contributor to, the patient's sleep disturbance
- Sleep medication (including over-the-counter), antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable (either in dose or regularity) for at least 3 months or is not expected to remain stable during the patient's participation in the study. Patients on a stable regimen, whose regimen is also expected to remain stable throughout the study, are eligible for participation;
- Proton Pump Inhibitor (PPI) use within 1 week prior to Screening. The only allowable acid modifying rescue medication is GELUSIL® during the run-in period. Only study medication and rescue medication (GELUSIL®) is allowed during the treatment period for treatment of acid mediated symptoms
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00660660
Start Date
April 1 2008
End Date
July 1 2008
Last Update
March 2 2015
Active Locations (45)
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1
Research Site
Huntsville, Alabama, United States
2
Research Site
Tucson, Arizona, United States
3
Research Site
Little Rock, Arkansas, United States
4
Research Site
Anaheim, California, United States