Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT00660660
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00660660
Study Brief:
Protocol Section:
NCT00660660