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

Sponsor

HK inno.N Corporation (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05701540

Collaborator

(none)

338

Enrollment

Location

Arms

Anticipated Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease	Drug: Tegoprazan Drug: Esomeprazole	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

338 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 2, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tegoprazan 50mg Tegoprazan 50mg, once daily, oral administration for two weeks	Drug: Tegoprazan Tegoprazan 50mg tablet
Active Comparator: Esomeprazole 40mg or 20mg In case of ERD patients: Esomeprazole 40mg, qd, oral administration for two weeks In case of NERD patients: Esomeprazole 20mg, qd, oral administration for two weeks	Drug: Esomeprazole Esomeprazole 20mg tablet For patients with ERD: two Esomeprazole 20mg tablets For patients with NERD: one Esomeprazole 20mg tablet

Arm

Intervention/Treatment

Experimental: Tegoprazan 50mg

Tegoprazan 50mg, once daily, oral administration for two weeks

Drug: Tegoprazan

Tegoprazan 50mg tablet

Active Comparator: Esomeprazole 40mg or 20mg

In case of ERD patients: Esomeprazole 40mg, qd, oral administration for two weeks In case of NERD patients: Esomeprazole 20mg, qd, oral administration for two weeks

Drug: Esomeprazole

Esomeprazole 20mg tablet For patients with ERD: two Esomeprazole 20mg tablets For patients with NERD: one Esomeprazole 20mg tablet

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects aged between 19 and 75 years
Subjects who have erosive reflux disease or non-erosive reflux disease

Exclusion Criteria:

Unable to undergo upper GI endoscopy
Symptoms of primary or secondary esophageal movement disorders
Subjects who have undergone or are scheduled to undergo surgery that can affect gastric acid secretion(e.g. upper gastrectomy, vagotomy, etc)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	03722

Sponsors and Collaborators

HK inno.N Corporation

Investigators

Principal Investigator: Sang Kil Lee, Ph.D, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

HK inno.N Corporation

ClinicalTrials.gov Identifier:

NCT05701540

Other Study ID Numbers:

IN_APA_403

First Posted:

Jan 27, 2023

Last Update Posted:

Jan 27, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastroesophageal Reflux

Heartburn

Esomeprazole

Study Results

No Results Posted as of Jan 27, 2023