This study aims to compare the nighttime heartburn improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.
This is a multi-center, double-blind, randomized, active-controlled phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg or 20mg).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
338
Tegoprazan 50mg tablet
Esomeprazole 20mg tablet 1. For patients with ERD: two Esomeprazole 20mg tablets 2. For patients with NERD: one Esomeprazole 20mg tablet
Severance Hospital
Seoul, South Korea
RECRUITINGPercentage of days without nighttime heartburn during the 2-week dosing period
Percentage of days without nighttime heartburn = Number of days without nighttime heartburn symptoms during the dosing period / Number of days when nighttime heartburn was assessed x 100
Time frame: 2 weeks
Time to first nighttime hearturn-free interval(days)
Number of days to reach the first day without symptoms of nighttime heartburn after the administration of investigational drug
Time frame: 2 weeks
Percentage of days without daytime heartburn during the 2-week dosing period
Percentage of days without daytime heartburn = Number of days without daytime heartburn symptoms during the dosing period / Number of days when daytime heartburn was assessed x 100
Time frame: 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.