Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US
