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

Erosive Reflux Disease Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 (Pilot) Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04309916
• Other study ID #: KCAB_002
• Status: Completed
• Phase: Phase 4
• Start date: May 22, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: February 2022
• Source: HK inno.N Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Dyssomnias
• Erosive Reflux Disease
• Heartburn
• Parasomnias

Intervention

Drug:
• Tegoprazan
Tegoprazan 50mg tablet
• Esomeprazole
Esomeprazole 40mg tablet

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first nighttime heartburn-free interval (days))	Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials.	2 week
Secondary	Percentage of days without nighttime heartburn during the 2-week dosing period	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	2 week