NCT04309916 is a Phase 4 clinical trial of Tegoprazan in Erosive Reflux Disease, sponsored by HK inno.N Corporation.

Who is sponsoring NCT04309916?

NCT04309916 is sponsored by HK inno.N Corporation.

What drugs are being tested in NCT04309916?

Interventions in NCT04309916: Tegoprazan, Esomeprazole.

What condition does NCT04309916 study?

NCT04309916 studies Erosive Reflux Disease.

Is NCT04309916 still recruiting?

NCT04309916 is currently completed. Last updated 25 February 2022.

Last reviewed 2022-02-25 · How we verify

NCT04309916

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 25 February 2022

What this trial tests

Phase 4 trial testing Tegoprazan in Erosive Reflux Disease in 46 participants. Completed in 30 November 2021.

Timeline

22 May 2020

Primary endpoint
30 November 2021

30 November 2021

Quick facts

Lead sponsor	HK inno.N Corporation
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	46
Start date	22 May 2020
Primary completion	30 November 2021
Estimated completion	30 November 2021
Sites	1 location across South Korea

Drugs / interventions tested

Tegoprazan — full drug profile →
Esomeprazole (esomeprazole) — full drug profile →

Conditions studied

Erosive Reflux Disease — all drugs for Erosive Reflux Disease →

Sponsor

HK inno.N Corporation — full company profile →

Who can join

Adults 19 to 75, any sex, with Erosive Reflux Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Effects of Tegoprazan Versus Esomeprazole on Nighttime Heartburn and Sleep Quality in Gastroesophageal Reflux Disease: A Multicenter Double-blind Randomized Controlled Trial.
Kim JS, Seo SI, Kang SH, Lee SK, et al · · 2023 · cited 20× · PMID 36581325 · DOI 10.5056/jnm22104
UEG Week 2022 Poster Presentations
· 2022

Verify or expand the search:

Other trials of Tegoprazan

Trials testing the same drug.

NCT07277712 — A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers · Phase 1 · not yet recruiting
NCT06743243 — Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia · Phase 4 · enrolling by invitation
NCT06977841 — Tegoprazan-Based Therapies for H. Pylori Eradication: A Randomized Controlled Trial · NA · completed
NCT06894992 — Tegoprazan And Lansoprazole Effectiveness in Bleeding Peptic Ulcer Treatment · NA · recruiting
NCT07242456 — Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID fo · Phase 2, PHASE3 · recruiting

Other HK inno.N Corporation trials

Trials by the same sponsor.

NCT07277712 — A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers · Phase 1 · not yet recruiting
NCT07192263 — Study to Evaluate the Efficacy and Safety of IN-B00009 Injection in Adults With Obesity or Overweight Without Diabetes M · Phase 3 · not yet recruiting
NCT06736912 — This Study Aims to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties and Food Effect of · Phase 1 · not yet recruiting
NCT06725355 — To Compare the Pharmacokinetics and Safety After a Single Dose Administration of IN-G00002 and IN-R00002 in Healthy Adul · Phase 1 · active not recruiting
NCT06332638 — PK, PD and Safety of Tegoprazan 12.5 mg After Oral Administration in Healthy Subjects · Phase 1 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04309916 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by HK inno.N Corporation
Last refreshed: 25 February 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04309916.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing