Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)
1 other identifier
interventional
276
1 country
45
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) taken daily in relieving nighttime heartburn and problems sleeping in patients with gastroesophageal reflux disease (GERD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2008
Shorter than P25 for phase_4
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 15, 2008
CompletedFirst Posted
Study publicly available on registry
April 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
March 2, 2015
CompletedMarch 2, 2015
February 1, 2015
3 months
April 15, 2008
June 12, 2009
February 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.
Relief of nighttime heartburn on patient's last 7 days in the study. Relief was defined as a daily diary card response of "none" or 0, on at least 6 of 7 days, allowing for one "mild" or 1 response. Diary card scale (none, mild, moderate, severe).
Days 21- 28 (for early dropouts the last 7 days staying in the study)
Secondary Outcomes (46)
Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline
Baseline and 4 weeks
Achievement of Developer-defined Good Sleep
4 weeks
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.
1 week
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.
2 weeks
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.
4 weeks
- +41 more secondary outcomes
Study Arms (2)
Nexium 20mg
EXPERIMENTALNexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Placebo
PLACEBO COMPARATORInterventions
Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (45)
Research Site
Huntsville, Alabama, United States
Research Site
Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Burbank, California, United States
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Castro Valley, California, United States
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Orange, California, United States
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San Diego, California, United States
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Boynton Beach, Florida, United States
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Coral Springs, Florida, United States
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DeLand, Florida, United States
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Hollywood, Florida, United States
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Jupiter, Florida, United States
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Pembroke Pines, Florida, United States
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South Miami, Florida, United States
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Tampa, Florida, United States
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Zephyrhills, Florida, United States
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Stockbridge, Georgia, United States
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Overland Park, Kansas, United States
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Lexington, Kentucky, United States
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Hollywood, Maryland, United States
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Las Vegas, Nevada, United States
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Medford, New Jersey, United States
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Perth Amboy, New Jersey, United States
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West Orange, New Jersey, United States
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Albuquerque, New Mexico, United States
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Binghamton, New York, United States
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Huntersville, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Kettering, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Chattanooga, Tennessee, United States
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Johnson City, Tennessee, United States
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Amarillo, Texas, United States
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Fort Worth Dallas, Texas, United States
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Houston, Texas, United States
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Ogden, Utah, United States
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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
Related Publications (1)
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.
PMID: 25478944DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Transparency
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Tore Lind, MD
AstraZeneca
- STUDY DIRECTOR
Kurt Brown, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
David Johnson, MD
Eastern Virginia Medical School
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2008
First Posted
April 17, 2008
Study Start
April 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
March 2, 2015
Results First Posted
March 2, 2015
Record last verified: 2015-02