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:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT03020550
Eligibility Criteria:
Inclusion Criteria:
* Adults ages 21-70 years old
* Heartburn symptoms 3 or more days per week with an average daily symptom severity of 3 or more on a 7 day baseline symptom diary
* English language proficiency
* Willingness to be videotaped and connected to physiologic monitoring devices during the visit
Exclusion Criteria:
* Diagnosis of Crohn's disease, systemic sclerosis, known active ulcer disease, gastric cancer, or untreated/active Barrett's esophagitis based on subject self-report and/or medical record review
* Heavy alcohol use (\> 6 drinks/week for women and \> 13 drinks/week for men)
* Pregnant women.
* Dementia or significant memory difficulties
* Severe, unstable psychiatric disease
* Greater than 15 doses of nonsteroidal anti-inflammatory drugs (NSAIDS) within the prior 30 days (aspirin ≤ 325 mg daily permitted) or ongoing NSAID use at a level deemed likely to interfere with the study
* Failure to complete the baseline symptom diary for at least 6 of 7 days
* Change in GERD treatment regimen within the last 2 weeks (subjects may use antacids, H2 receptor blockers, and/or proton pump inhibitors as long as they are symptomatic on a stable regimen)
* Allergy to adhesives
* Inability to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT03020550
Study Brief:
Protocol Section:
NCT03020550