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

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Gastroesophageal Reflux Disease

Treatments

Drug: Esomeprazole

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00660660

D9612L00122

Details and patient eligibility

About

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).

Enrollment

276 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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