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

HK inno.N

Status and phase: Enrolling; Phase 4

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Esomeprazole; Drug: Tegoprazan

Study type: Interventional

Funder types: Industry

Identifiers

NCT05701540

IN_APA_403

Details and patient eligibility

About

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

Full 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).

Enrollment: 338 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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338 participants in 2 patient groups

Tegoprazan 50mg

Experimental group

Description:

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

Treatment:

Drug: Tegoprazan

Esomeprazole 40mg or 20mg

Active Comparator group

Description:

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

Treatment:

Drug: Esomeprazole