Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features
Launched by ST. LUKE'S MEDICAL CENTER, PHILIPPINES · Jul 19, 2019
Trial Information
Current as of June 15, 2025
Terminated
Keywords
ClinConnect Summary
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 Practice Guideline on the Diagnosis and Treatment of GERD defined is as a condition resulting from recurrent backflow of gastric contents into the esophagus and adjacent structures causing troublesome symptoms and/or tissue injury. It is a commonly encountered disorder in the clinics and daily practice. A clinical diagnosis of GERD is acceptable with typical symptoms of acid regurgitation and/or ...
Gender
ALL
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)
About St. Luke's Medical Center, Philippines
St. Luke's Medical Center, located in the Philippines, is a premier healthcare institution renowned for its commitment to excellence in patient care, medical research, and education. As a leading clinical trial sponsor, the center is dedicated to advancing medical knowledge and improving treatment outcomes through rigorous clinical research. With state-of-the-art facilities and a multidisciplinary team of experts, St. Luke's actively participates in innovative studies across various therapeutic areas, ensuring adherence to the highest ethical and regulatory standards. The institution's collaborative approach fosters partnerships with local and international organizations, positioning it at the forefront of clinical research in the region.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Quezon City, National Capital Region, Philippines
Patients applied
Trial Officials
Nicodemus L Ong, MD
Principal Investigator
Institute of Digestive and Liver Diseases, St. Luke's Medical Center, Quezon City
Sherrie Isabel Q De Ocampo, MD
Principal Investigator
Institute of Digestive and Liver Diseases, St. Luke's Medical Center, Quezon City
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials