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

Phase 4

Recruiting

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Esomeprazole; Drug: Tegoprazan

• Registration Number: NCT05701540
• Lead Sponsor: HK inno.N Corporation

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-27
• Study Start: 2023-03-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-03
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 338

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esomeprazole 40mg or 20mg	Esomeprazole	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
Tegoprazan 50mg	Tegoprazan	Tegoprazan 50mg, once daily, oral administration for two weeks

Primary Outcome Measures

Name	Time	Method
Percentage of days without nighttime heartburn during the 2-week dosing period	2 weeks	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

Secondary Outcome Measures

Name	Time	Method
Time to first nighttime hearturn-free interval(days)	2 weeks	Number of days to reach the first day without symptoms of nighttime heartburn after the administration of investigational drug
Percentage of days without daytime heartburn during the 2-week dosing period	2 weeks	Percentage of days without daytime heartburn = Number of days without daytime heartburn symptoms during the dosing period / Number of days when daytime heartburn was assessed x 100

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of