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

NCT06751121 | Completed Phase 3

• 1 other identifier: DW_DWP14012310
• Study Type: interventional
• Target: 461
• Locations: 1 country
• Sites: 1

Brief 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 Infected Patients; Helicobacter Pylori Infected Subjects; Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• H. pylori eradication rate

  H. pylori eradication rate identified by 13C-UBT after at least 4 weeks (28 - 56 days) from the end of treatment

  after at least 4 weeks (28 - 56 days) from the end of treatment

Secondary Outcomes (2)

• H. pylori eradication rate(for subjects who are resistant to clarithromycin)

  after at least 4 weeks (28 - 56 days) from the end of treatment

• H. pylori eradication rate(for subjects who are not resistant to clarithromycin or amoxicillin)

  after at least 4 weeks (28- 56 days) from the end of treatment

Study Arms (2)

DWP14012 40 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg

EXPERIMENTAL

1 tablet of DWP14012 40 mg + 1 capsule of DWC202301 30 mg placebo + amoxicillin 1000 mg (2 capsules of 500 mg) + 1 tablet of clarithromycin 500 mg

Drug: DWP14012 40mg; Drug: Amoxicillin 1000mg; Drug: Clarithromycin 500mg; Drug: DWC202301 30mg placebo

DWC202301 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg

ACTIVE COMPARATOR

1 tablet of DWP14012 40 mg placebo + 1 capsule of DWC202301 30 mg + amoxicillin 1000 mg (2 capsules of 500 mg) + 1 tablet of clarithromycin 500 mg

Drug: DWC202301 30mg; Drug: Amoxicillin 1000mg; Drug: Clarithromycin 500mg; Drug: DWP14012 40mg placebo

Interventions

DWP14012 40mg DRUG

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).

DWP14012 40 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg

DWC202301 30mg DRUG

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).

DWC202301 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg

Amoxicillin 1000mg DRUG

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).

DWC202301 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg; DWP14012 40 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg

Clarithromycin 500mg DRUG

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)

DWC202301 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg; DWP14012 40 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg

DWC202301 30mg placebo DRUG

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)

DWP14012 40 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg

DWP14012 40mg placebo DRUG

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)

DWC202301 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females ≥19 and ≤75 years of age at the time of giving informed consent
• Those who have all positive test results for H. pylori (13C-urea breath test and CLO) at screening visit (Visit 1)
• A positive 13C-UBT result
• A positive CLO result
• Those who require treatment for H. pylori eradication as at least one of the following applies:
• Those who have peptic ulcer (gastric ulcer or duodenal ulcer) based on an upper gastrointestinal (GI) endoscopy at screening visit (Visit 1)
• Those who have chronic atrophic gastritis based on an upper GI endoscopy at screening visit (Visit 1)
• Those with a history of endoscopic resection of early gastric cancer or gastric adenoma

You may not qualify if:

• Those with significant upper GI bleeding
• Those with a history of a surgical procedure that might affect gastric acid secretion (upper GI resection or vagotomy), or who are scheduled to undergo such procedure during this study
• Those with Zollinger-Ellison syndrome or other gastric acid hypersecretion disorders
• Those with a history of treatment for H. pylori eradication
• Those with a history of any malignancy within recent 5 years prior to screening visit (Visit 1)
• However, they can participate if 5 years have passed without recurrence after determined to achieve a complete remission (the complete removal of tumors through surgical procedures or the end of anticancer therapy)
• Those who have experienced acute coronary artery disease (unstable angina, myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention), peripheral arterial disease and cerebrovascular disease (transient ischemic attack, stroke) within 24 weeks prior to screening visit (Visit 1)
• Those with clinically significant systemic bleeding disorders, coagulation disorders, or severe blood disorders that make them ineligible for participation in this study
• Those with acquired immunodeficiency syndrome (AIDS) or viral hepatitis (tested positive for HBs antigen or HCV antibody) (However, subjects who are negative for HCV-RNA can participate.)
• Those who meet the following criteria according to the results of the hepatic or renal level test performed at screening visit (Visit 1)
• At least one of ALT, AST, ALP, γ-GTP and total bilirubin \> 2 times the upper limit of normal
• BUN \> 2 times the upper limit of normal
• Creatinine clearance (CrCl) ≤ 30 mL/min
• Patients with uncontrolled hypertension (systolic blood pressure of ≥ 160 mmHg or diastolic blood pressure of ≥ 100 mmHg at screening)
• Patients with uncontrolled diabetes (HbA1c \> 9.0 % at screening)

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

fexuprazan; Amoxicillin; Clarithromycin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: February 6, 2024
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)