Skip to main content
OpenTrials
Completed

NCT Number: NCT04309916

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Erosive Reflux Disease

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 03722, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects aged between 19 and 75 years
  • Subjects who have erosive reflux disease

Exclusion criteria

  • Unable to undergo upper GI endoscopy
  • Symptoms of primary or secondary esophageal movement disorders
  • Planning or Perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, Vagotomy, etc.)

Treatment and study plan

Tegoprazan

Drug

Tegoprazan 50mg tablet

Esomeprazole

Drug

Esomeprazole 40mg tablet

Primary outcomes

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

    Time frame: 2 week

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

Secondary outcomes

  1. Percentage of days without nighttime heartburn during the 2-week dosing period

    Time frame: 2 week

    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

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 (Pilot) Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2020
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.