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

Phase 3

Completed

• Conditions: Acute Gastritis; Chronic Gastritis
• Interventions: Drug: DWP14012 X mg; Drug: DWP14012 X mg placebo; Drug: DWP14012 Y mg placebo; Drug: DWP14012 Y mg

• Registration Number: NCT04341454
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Study Timeline

• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-10
• Study Start: 2020-06-02
• Primary Completion: 2021-08-04
• Study Completion: 2021-09-16
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP14012 X mg QD	DWP14012 X mg	* Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo * Evening: 1 tablet of DWP14012 Y mg placebo
placebo	DWP14012 X mg placebo	* Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo * Evening: 1 tablet of DWP14012 Y mg placebo
placebo	DWP14012 Y mg placebo	* Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg placebo * Evening: 1 tablet of DWP14012 Y mg placebo
DWP14012 Y mg BID	DWP14012 Y mg	* Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg * Evening: 1 tablet of DWP14012 Y mg
DWP14012 X mg QD	DWP14012 Y mg placebo	* Morning: 1 tablet of DWP14012 X mg + 1 tablet of DWP14012 Y mg placebo * Evening: 1 tablet of DWP14012 Y mg placebo
DWP14012 Y mg BID	DWP14012 X mg placebo	* Morning: 1 tablet of DWP14012 X mg placebo + 1 tablet of DWP14012 Y mg * Evening: 1 tablet of DWP14012 Y mg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 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

Trial Locations

Locations (1)

Hanyang University Medical Center; 🇰🇷 Seoul, Korea, Republic of