NCT06751121

Study to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter Pylori

A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter Pylori

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 461 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to demonstrate the non-inferiority and verify the safety of DWP14012-based triple therapy compared to DWC202301-based triple therapy as the first-line eradication therapy in patients who are positive for Helicobacter pylori

Conditions

• Helicobacter Pylori Infection
• Helicobacter Pylori Infected Patients
• Helicobacter Pylori Infected Subjects

Interventions

Type	Name	Description
DRUG	DWP14012 40mg	DWP14012 40 mg, tablet, orally, twice daily before a meal with the concomitant medications at the same time each day, if possible, during the treatment period (14 days).
DRUG	DWC202301 30mg	DWC202301 30 mg, capsule, orally, twice daily before a meal with the concomitant medications at the same time each day, if possible, during the treatment period (14 days).
DRUG	Amoxicillin 1000mg	Amoxicillin 1000 mg(2 capsules of 500mg), capsule, orally, twice daily before a meal with the concomitant medications at the same time each day, if possible, during the treatment period (14 days).
DRUG	Clarithromycin 500mg	Clarithromycin 500 mg, tablet, orally, twice daily before a meal with the concomitant medications at the same time each day, if possible, during the treatment period (14 days)
DRUG	DWC202301 30mg placebo	DWC202301 30 mg placebo, capsule, orally, twice daily before a meal with the concomitant medications at the same time each day, if possible, during the treatment period (14 days)
DRUG	DWP14012 40mg placebo	DWP14012 40 mg placebo, tablet, orally, twice daily before a meal with the concomitant medications at the same time each day, if possible, during the treatment period (14 days)

Timeline

• Start date: 2024-02-06
• Primary completion: 2025-04-24
• Completion: 2025-04-24
• First posted: 2024-12-27
• Last updated: 2025-12-08

Locations

1 site across 1 country: South Korea