Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis

A Multi-Center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04341454

Enrollment

327

Registered

2020-04-10

Start date

2020-06-02

Completion date

2021-09-16

Last updated

2021-12-21

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

Conditions

Acute Gastritis, Chronic Gastritis

Brief summary

The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo in patients with Acute or Chronic Gastritis

Detailed description

This study was designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to assess the efficacy and safety of oral administration of DWP14012 X mg QD, Y mg BID and placebo for 2 weeks in patients with acute and chronic gastritis.

Interventions

DRUGDWP14012 X mg

DWP14012 X mg, tablet, orally, once daily for 2 weeks

DRUGDWP14012 X mg placebo

DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks

DRUGDWP14012 Y mg

DWP14012 Y mg, tablet, orally, twice daily for 2 weeks

DRUGDWP14012 Y mg placebo

DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Adults between 19 and 75 years old based on the date of written agreement * Those who are diagnosed with acute or chronic gastritis with at least one erosion observed on upper gastrointestinal endoscopy * Those who had experienced one or more subjective symptoms of gastritis

Exclusion criteria

* Those who have had surgery to reduce gastric acid secretion, or gastric or esophageal surgery * Those with history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that could affect the study results

Design outcomes

Primary

Measure	Time frame	Description
Improvement rate of gastric mucosal erosion	at 2 weeks after the IP administration	Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erosion score) / Number of target cases) x 100

Secondary

Measure	Time frame	Description
Cure rate of gastric mucosal erosion	at 2 weeks after the IP administration	Cure rate (%) = (Number of healed cases(0 erosions) / Number of target cases) x 100
Cure rate of gastric mucosal edema	at 2 weeks after the IP administration	Cure rate (%) = (Number of healed cases(change of 2 to 1 in edema score) / Number of target cases) x 100
Improvement rate of gastric mucosal erythema	at 2 weeks after the IP administration	Improvement rate (%) = (Number of effective cases(change of ≥ 50% in erythema score) / Number of target cases) x 100
Improvement rate of gastric mucosal bleeding	at 2 weeks after the IP administration	Improvement rate (%) = (Number of effective cases(change of ≥ 50% in bleeding score) / Number of target cases) x 100
Improvement rate of subjective symptoms	at 2 weeks after the IP administration	Improvement rate (%) = (Number of effective cases(change of ≥ 50% in subjective symptom score) / Number of target cases) x 100

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026