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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT01777867
Eligibility Criteria:
Inclusion Criteria:
* symptomatic reflux (i.e., one symptom at least one day a week, with at least 'moderate' severity)
* no evidence of esophagitis
* non-smokers
Exclusion Criteria:
* previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy
* active peptic ulcer disease
* Zollinger Ellison Syndrome
* Barrett's esophagus
* eosinophilic esophagitis
* cardiac disease
* diabetes or neurological deficit
* use of tricyclics
* selective serotonin reuptake inhibitors
* narcotics or benzodiazepines
* current use of medications that may affect symptoms of perception,lower esophageal sphincter basal pressure, acid clearance time or acid suppression
* antibiotics within 60 days
* Nursing mothers will be excluded
* allergies to citrus
* asthma
* chronic lung disease
* heart attack or stroke within the last three months
* hypersensitivity to methacholine products
* know aortic aneurysm
* uncontrolled hypertension (defined as systolic pressure greater than 200 or diastolic greater than 100)
* reduced pulmonary function test (forced expiratory volume in one second (FEV1) or the FEV1 to forced vital capacity (FVC) ratio (FEV1/FVC) of less that 70% of predicted value)
* None of the controls will have any GERD symptoms or ever used antireflux treatment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01777867
Study Brief:
Protocol Section:
NCT01777867