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

HK inno.N

Status and phase: Completed; Phase 4

Conditions: Erosive Reflux Disease

Treatments: Drug: Esomeprazole; Drug: Tegoprazan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04309916

KCAB_002

Details and patient eligibility

About

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

Full 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)

Enrollment: 46 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups

Tegoprazan 50mg

Experimental group

Description:

Tegoprazan 50mg tablet, once daily, oral administration

Treatment:

Drug: Tegoprazan

Esomeprazole 40mg

Active Comparator group

Description:

Esomeprazole 40mg tablet, once daily, oral administration

Treatment:

Drug: Esomeprazole