Status:
TERMINATED
Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features
Lead Sponsor:
St. Luke's Medical Center, Philippines
Conditions:
GERD
Gastro Esophageal Reflux
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Gastroesophageal reflux disease is a commonly encountered disorder in daily practice. Proton pump inhibitor therapy has been the cornerstone of treatment for decades. Although it has been proven to be...
Detailed Description
Gastroesophageal Reflux Disease (GERD) is globally defined as a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. The Philippine Clinical Pr...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04028466
Start Date
May 26 2019
End Date
March 30 2020
Last Update
November 22 2023
Active Locations (1)
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1
St. Luke's Medical Center
Quezon City, National Capital Region, Philippines, 1112