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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701540
• Other study ID #: IN_APA_403
• Status: Recruiting
• Phase: Phase 4
• Start date: March 24, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: HK inno.N Corporation
• Contact: Tae Hoon Kim
• Phone: 82-2-6477-0244
• Email: luke.kim[@]inno-n.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 338
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• 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 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)

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Heartburn

Intervention

Drug:
• Tegoprazan
Tegoprazan 50mg tablet
• Esomeprazole
Esomeprazole 20mg tablet For patients with ERD: two Esomeprazole 20mg tablets For patients with NERD: one Esomeprazole 20mg 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	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 weeks
Secondary	Time to first nighttime hearturn-free interval(days)	Number of days to reach the first day without symptoms of nighttime heartburn after the administration of investigational drug	2 weeks
Secondary	Percentage of days without daytime heartburn during the 2-week dosing period	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	2 weeks