Efficacy and Safety of Tegoprazan in Patients with Erosive Gastroesophageal Reflux Disease- A Multicountry, Prospective, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study
Abstract
Background: Tegoprazan is a highly selective potassium-competitive acid blocker (P-CAB) that delivers rapid relief and maintains an intragastric
pH above 4 after both single and multiple doses.
Objective: This study was aimed to determine the efficacy and safety of Tegoprazan in treating erosive gastroesophageal reflux disease (eGERD)
over a treatment period of 8 weeks.
Methods: The present study was a randomized, double-blind, active-controlled, parallel-group multi-center, multi-country phase 3 clinical trial to
evaluate efficacy and safety of Tegoprazan 50 mg tablet in comparison to Esomeprazole 40 mg tablet in patients with eGERD. The study planned
to enroll male and non-pregnant female patients (18-65 years of age) with endoscopically confirmed eGERD classified as Los Angles (LA)
grades A-D. Following a screening period of approximately 14 days, eligible patients were randomized in 1:1 ratio to one of the two double-blind
treatment groups. The primary endpoint was the cumulative endoscopic healing rate of eGERD by 8 weeks based on the upper gastrointestinal
(GI) endoscopy. Symptoms, safety, and tolerability were also assessed. This trial is registered at Clinical Trial Registry of India (CTRI) and South
African National Clinical Trial Registry (SANCTR).
Results: Between November 2023 and July 2024, in a competitive recruitment process spanning three countries, 255 patients were enrolled:
179 from India, 69 from Russia, and 7 from South Africa. At week 8, cumulative…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 255 participants or records.
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