Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US
NCT ID: NCT00660660
Last Updated: 2015-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
276 participants
INTERVENTIONAL
2008-04-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nexium 20mg
Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Esomeprazole
Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo
Placebo
once daily
Interventions
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Esomeprazole
Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo
once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Tore Lind, MD
Role: STUDY_DIRECTOR
AstraZeneca
Kurt Brown, MD
Role: STUDY_DIRECTOR
AstraZeneca
David Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
Eastern Virginia Medical School
Locations
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Research Site
Huntsville, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Anaheim, California, United States
Research Site
Burbank, California, United States
Research Site
Castro Valley, California, United States
Research Site
Orange, California, United States
Research Site
San Diego, California, United States
Research Site
Boynton Beach, Florida, United States
Research Site
Coral Springs, Florida, United States
Research Site
DeLand, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Jupiter, Florida, United States
Research Site
Pembroke Pines, Florida, United States
Research Site
South Miami, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Zephyrhills, Florida, United States
Research Site
Stockbridge, Georgia, United States
Research Site
Overland Park, Kansas, United States
Research Site
Lexington, Kentucky, United States
Research Site
Hollywood, Maryland, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Medford, New Jersey, United States
Research Site
Perth Amboy, New Jersey, United States
Research Site
West Orange, New Jersey, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Binghamton, New York, United States
Research Site
Huntersville, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Dayton, Ohio, United States
Research Site
Kettering, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Johnson City, Tennessee, United States
Research Site
Amarillo, Texas, United States
Research Site
Fort Worth Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Ogden, Utah, United States
Research Site
Burke, Virginia, United States
Research Site
Christiansburg, Virginia, United States
Research Site
Fredericksburg, Virginia, United States
Research Site
Newport News, Virginia, United States
Research Site
Bellevue, Washington, United States
Countries
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References
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Johnson DA, Le Moigne A, Hugo V, Nagy P. Rapid resolution of sleep disturbances related to frequent reflux: effect of esomeprazole 20 mg in two randomized, double-blind, controlled trials. Curr Med Res Opin. 2015 Feb;31(2):243-50. doi: 10.1185/03007995.2014.991818. Epub 2015 Jan 9.
Related Links
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Other Identifiers
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D9612L00122
Identifier Type: -
Identifier Source: org_study_id
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