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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04309916

Enrollment

Registered

2020-03-17

Start date

2020-05-22

Completion date

2021-11-30

Last updated

2022-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive Reflux Disease

Brief summary

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

Detailed description

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)

Interventions

DRUGTegoprazan

Tegoprazan 50mg tablet

DRUGEsomeprazole

Esomeprazole 40mg tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

Yes

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.)

Design outcomes

Primary

Measure	Time frame	Description
Time to first nighttime heartburn-free interval (days))	2 week	Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials.

Secondary

Measure	Time frame	Description
Percentage of days without nighttime heartburn during the 2-week dosing period	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026