NCT04341454

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 327 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Gastritis
• Chronic Gastritis

Interventions

Type	Name	Description
DRUG	DWP14012 X mg	DWP14012 X mg, tablet, orally, once daily for 2 weeks
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
DRUG	DWP14012 Y mg placebo	DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks

Timeline

• Start date: 2020-06-02
• Primary completion: 2021-08-04
• Completion: 2021-09-16
• First posted: 2020-04-10
• Last updated: 2021-12-21

Locations

1 site across 1 country: South Korea