Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)

A Multi-Center, Randomized, Double-Blind, Active-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03736369

Enrollment

263

Registered

2018-11-09

Start date

2018-12-13

Completion date

2019-08-07

Last updated

2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive Esophagitis

Brief summary

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.

Interventions

DRUGDWP14012 40mg

DWP14012 40mg, tablet, orally, once daily for up to 8 weeks

DRUGDWP14012 40mg placebo

DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks

DRUGEsomeprazole 40mg

Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks

DRUGEsomeprazole 40mg placebo

Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Adults between 20 and 75 years old based on the date of written agreement * Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy * Those who experienced symptoms of heartburn or acid regurgitation within the last 7 days

Exclusion criteria

* Those who have undergone gastric acid suppression or gastric, esophageal surgery * Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease

Design outcomes

Primary

Measure	Time frame
Cumulative healing rate of erosive esophagitis at 8week by endoscopy	at 8week

Secondary

Measure	Time frame	Description
Cumulative healing rate of erosive esophagitis at 4week by endoscopy	at 4week	—
Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)	at 4week and 8week	Mean change of the frequency or severity of main symptoms
Quality of Life assessment using GERD-HRQL(GERD-Health related quality life)	at 4week and 8week	Mean change of the total score of GERD-HRQL

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026