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

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

Study Overview

• Status: Completed
• Conditions: Acute Gastritis; Chronic Gastritis
• Intervention / Treatment: Drug: DWP14012 X mg; Drug: DWP14012 Y mg placebo; Drug: DWP14012 X mg placebo; Drug: DWP14012 Y mg

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.

• Study Type: Interventional
• Enrollment (Actual): 327
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Hanyang University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DWP14012 X mg QD; Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo; Evening: 1 tablet of DWP14012 Y mg placebo	Drug: DWP14012 X mg; DWP14012 X mg, tablet, orally, once daily for 2 weeks; Drug: DWP14012 Y mg placebo; DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks
Experimental: DWP14012 Y mg BID; Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg; Evening: 1 tablet of DWP14012 Y mg	Drug: DWP14012 X mg placebo; DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks; Drug: DWP14012 Y mg; DWP14012 Y mg, tablet, orally, twice daily for 2 weeks
Placebo Comparator: placebo; Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo; Evening: 1 tablet of DWP14012 Y mg placebo	Drug: DWP14012 Y mg placebo; DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks; Drug: DWP14012 X mg placebo; DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2020
• Primary Completion (Actual): August 4, 2021
• Study Completion (Actual): September 16, 2021

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Gastritis, Atrophic
• Other Study ID Numbers: DW_DWP14012305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No