Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance

HK inno.N Corporation46 enrolled

Overview

This study aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.

This is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Erosive Reflux Disease

Interventions

TegoprazanDRUG

Tegoprazan 50mg tablet

EsomeprazoleDRUG

Esomeprazole 40mg tablet

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects aged between 19 and 75 years 2. Subjects who have erosive reflux disease Exclusion Criteria: 1. Unable to undergo upper GI endoscopy 2. Symptoms of primary or secondary esophageal movement disorders 3. Planning or Perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, Vagotomy, etc.)

Locations (1)

Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Time to first nighttime heartburn-free interval (days))

Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials.

Time frame: 2 week

Secondary Outcomes

Percentage 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 week

Data from ClinicalTrials.gov

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