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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-24

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tegoprazan 50mg

Tegoprazan 50mg, once daily, oral administration for two weeks

Group Type EXPERIMENTAL

Tegoprazan

Intervention Type DRUG

Tegoprazan 50mg tablet

Esomeprazole 40mg or 20mg

1. In case of ERD patients: Esomeprazole 40mg, qd, oral administration for two weeks
2. In case of NERD patients: Esomeprazole 20mg, qd, oral administration for two weeks

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

Esomeprazole 20mg tablet

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

Interventions

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Tegoprazan

Tegoprazan 50mg tablet

Intervention Type DRUG

Esomeprazole

Esomeprazole 20mg tablet

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No