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

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-22

Study Completion Date

2021-11-30

Brief Summary

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

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Detailed Description

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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)

Conditions

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Erosive 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 tablet, once daily, oral administration

Group Type EXPERIMENTAL

Tegoprazan

Intervention Type DRUG

Tegoprazan 50mg tablet

Esomeprazole 40mg

Esomeprazole 40mg tablet, once daily, oral administration

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

Esomeprazole 40mg tablet

Interventions

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Tegoprazan

Tegoprazan 50mg tablet

Intervention Type DRUG

Esomeprazole

Esomeprazole 40mg 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

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.)

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes