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

NCT06751121 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 461

Last updated 2025-12-08

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Daewoong Pharmaceutical Co. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-06
Primary Completion
2025-04-24
Completion
2025-04-24

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06751121 on ClinicalTrials.gov