Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US

Completed · Phase 4 · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease

In brief

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).

Key facts

Study ID

NCT00660660

Run by

AstraZeneca

People needed

276

Starts

2008-04-01

Expected to finish

2008-07-01

Last updated by the study team

2015-03-02

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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