A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn

A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05701540

Enrollment

338

Registered

2023-01-27

Start date

2023-03-24

Completion date

2024-12-31

Last updated

2023-08-03

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

Conditions

Gastroesophageal Reflux Disease

Brief summary

This study aims to compare the nighttime heartburn improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.

Detailed description

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).

Interventions

DRUGTegoprazan

Tegoprazan 50mg tablet

DRUGEsomeprazole

Esomeprazole 20mg tablet 1. For patients with ERD: two Esomeprazole 20mg tablets 2. For patients with NERD: one Esomeprazole 20mg 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

Inclusion criteria

1. Subjects aged between 19 and 75 years 2. Subjects who have erosive reflux disease or non-erosive reflux disease

Exclusion criteria

1. Unable to undergo upper GI endoscopy 2. Symptoms of primary or secondary esophageal movement disorders 3. Subjects who have undergone or are scheduled to undergo surgery that can affect gastric acid secretion(e.g. upper gastrectomy, vagotomy, etc)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Time to first nighttime hearturn-free interval(days)	2 weeks	Number of days to reach the first day without symptoms of nighttime heartburn after the administration of investigational drug
Percentage of days without daytime heartburn during the 2-week dosing period	2 weeks	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

Countries

South Korea

Contacts

Primary ContactTae Hoon Kim

luke.kim@inno-n.com82-2-6477-0244

Backup ContactJong Min Lee

jongmin.lee6@inno-n.com82-2-6477-0251

Outcome results

None listed

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