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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT04028466
Eligibility Criteria:
Inclusion Criteria:
* All Adult patients with clinically diagnosed with Gastroesophageal Reflux Disease (GERD) without alarm features (heartburn and acid regurgitation)
* Age more than 18 years at the time of written consent
* Those who provide written consent with their own free will
* Both treatment naïve and treatment experienced patients will be included. Treatment experienced patients should not be taking any proton pump inhibitors for 2 weeks to allow for washout period.
Exclusion Criteria:
* Patients that have alarm features as defined by the Philippines Guidelines for GERD (dysphagia, odynophagia, weight loss, anemia, hematemesis, family history of esophageal adenocarcinoma, nocturnal choking, abdominal mass, recurrent/frequent vomiting, chest pain)
* Patients with atypical GERD symptoms (cough, laryngitis, chest pain, etc.)
* Patients already taking proton pump inhibitors for the past 2 weeks
* Patients who scored less than 8 on the FSSG questionnaire
* Patients who have undergone gastroesophageal surgery
* Patients who are poorly compliant to medications
* allergy to PPI or vonoprazan
* With serious comorbidities, such as but not limited to: heart failure, renal failure, malignancy or hepatic failure
* Pregnant, breastfeeding or possibly pregnant
* Patients that would not provide consent
* Patients who are unable to complete the FSSG Questionnaire independently
* Patients who are unable to follow up at designated periods
* Patients taking rilpivirine or atazanavir.
* Patients with elevated baseline liver function tests (more than twice the upper limit of normal)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04028466
Study Brief:
Protocol Section:
NCT04028466