NCT03736369 is a Phase 3 clinical trial of DWP14012 40mg in Erosive Esophagitis, sponsored by Daewoong Pharmaceutical Co. LTD..

Who is sponsoring NCT03736369?

NCT03736369 is sponsored by Daewoong Pharmaceutical Co. LTD..

What drugs are being tested in NCT03736369?

Interventions in NCT03736369: DWP14012 40mg, DWP14012 40mg placebo, Esomeprazole 40mg, Esomeprazole 40mg placebo.

What condition does NCT03736369 study?

NCT03736369 studies Erosive Esophagitis.

Is NCT03736369 still recruiting?

NCT03736369 is currently completed. Last updated 3 September 2020.

Last reviewed 2020-09-03 · How we verify

NCT03736369

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 DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)

Completed Phase 3 Last updated 3 September 2020

What this trial tests

Phase 3 trial testing DWP14012 40mg in Erosive Esophagitis in 263 participants. Completed in 7 August 2019.

Timeline

13 December 2018

Primary endpoint
7 August 2019

7 August 2019

Quick facts

Lead sponsor	Daewoong Pharmaceutical Co. LTD.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	263
Start date	13 December 2018
Primary completion	7 August 2019
Estimated completion	7 August 2019
Sites	1 location across South Korea

Drugs / interventions tested

DWP14012 40mg — full drug profile →
DWP14012 40mg placebo
Esomeprazole 40mg — full drug profile →
Esomeprazole 40mg placebo

Conditions studied

Erosive Esophagitis — all drugs for Erosive Esophagitis →

Sponsor

Daewoong Pharmaceutical Co. LTD. — full company profile →

Who can join

Adults 20 to 75, any sex, with Erosive Esophagitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.

Publications & conference data

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

Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis.
Lee KN, Lee OY, Chun HJ, Kim JI, et al · · 2022 · cited 43× · PMID 36504556 · DOI 10.3748/wjg.v28.i44.6294
RETRACTED: A Phase III Head-to-Head Study to Compare the Efficacy and Safety of Fexuprazan and Esomeprazole in Treating Patients with Erosive Esophagitis.
Jeong Y, Lee BJ, Han SH. · · 2024 · cited 2× · PMID 38892973 · DOI 10.3390/jcm13113262
Fexuprazan and Esomeprazole in Patients with Disorders Associated with Acid Reflux: A Comprehensive Review and Meta-Analysis of Randomized Controlled Trials.
Barzola-Farfán WA, Quispe-Vicuña C, Rivera-Lozada O, Bonilla-Asalde C, et al · · 2026 · PMID 41753122 · DOI 10.3390/jcm15041434
UEG Week 2024 Moderated Posters
· 2024

Verify or expand the search:

Other trials of DWP14012 40mg

Trials testing the same drug.

NCT06751121 — Study to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter Pylori · Phase 3 · completed

Other recruiting trials for Erosive Esophagitis

Currently open trials in the same condition.

NCT02615184 — A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in C · Phase 2 · active not recruiting
NCT05267613 — Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis. · Phase 3 · recruiting
NCT04255693 — Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence · NA · recruiting

Other Daewoong Pharmaceutical Co. LTD. trials

Trials by the same sponsor.

NCT07515560 — Efficacy and Safety of Baroezet Tablet in Korean Patients With Dyslipidemia: A Prospective Observational Study · not yet recruiting
NCT07516977 — Noseguard for Prevention of Respiratory Infections in Real-World Use · NA · not yet recruiting
NCT07539415 — A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Hea · Phase 1 · not yet recruiting
NCT07267221 — Bioequivalence Study for the Safety and the Pharmacokinetics of DWC202313, DWC202314, and DWJ1622 in Healthy Volunteers · Phase 1 · recruiting
NCT07256600 — PK and Safety Comparison of DWJ445 and DWC202506 in Healthy Volunteers · Phase 1 · completed

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 NCT03736369 (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 Daewoong Pharmaceutical Co. LTD.
Last refreshed: 3 September 2020

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/NCT03736369.

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