Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features

• Status: Unknown status
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

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 highly effective, there is still room for improvement. A local study showed that only 57.3% of subjects are asymptomatic after 4 weeks treatment with rabeprazole. Recently a new drug was developed with better absorption, higher bioavailability, more sustained increased pH in the stomach and more targeted action to the H-K ATPase pump. Vonoprazan, belongs to a new class of acid suppressant medications, the potassium-competitive acid blocker (P-CAB). Vonoprazan has been studied and used successfully in Japan for H pylori eradication therapy, GERD, gastric and duodenal ulcers with favorable safety profile. However, to the author's knowledge, no study yet exists comparing vonoprazan to a proton pump inhibitor in the treatment of GERD outside Japan. This study aims to determine whether vonoprazan is superior to omeprazole in relieving symptoms in treatment-naïve adult patients with GERD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Luke's Medical Center, Philippines
• Treatments: Omeprazole

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)