Helicobacter Pylori InfectionPhase 3NCT06751121
Study to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacter Pylori
A Phase 3 study testing DWP14012 40mg, DWC202301 30mg and Amoxicillin 1000mg in people with Helicobacter Pylori Infection and Helicobacter Pylori Infected Patients, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection, Helicobacter Pylori Infected Patients, Helicobacter Pylori Infected Subjects
- What is being tested?
- DWP14012 40mg, DWC202301 30mg and Amoxicillin 1000mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 461 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Feb 2024to 24 Apr 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 47Show fewer
- Still, those with a history of malignancies in the digestive system, except early gastric cancer under the inclusion criteria, are excluded irrespective of a complete remission
- 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)
- Patients with one or more of the following:
- Heart failure (NYHA Class III ~ IV)
- History of QT prolongation or ventricular arrhythmias (including Torsades de pointes)
- Patients with hypokalemia (Potassium < 3 mmol/L at screening)
- Patients with hypomagnesemia (Magnesium < 1.2 mg/dL at screening)
- Those with clinically significant mental disorders
- Patients with central nervous system infection
- Patients with infectious mononucleosis
- Those with a history of drug or alcohol abuse within recent 1 year prior to screening visit (Visit 1)
- Those with a history of hypersensitivity or allergy to the IP, amoxicillin, clarithromycin, drugs used for 13C-UBT, or premedications for an upper GI endoscopy, or their components
- Those with a history of hypersensitivity or allergy to proton pump inhibitors (PPIs), potassium-competitive acid blockers (P-CABs), benzimidazoles, penicillin antibiotics, or macrolide antibiotics
- Those who are taking, or need to take, at least one of the following:
- Atazanavir, Rilpivirine, or drugs that contain any of them
- Pimozide, Domperidone
- Ergot alkaloid and its derivatives (Ergotamine, Dihydroergotamine, etc.)
- Mizolastine
- Ticagrelor
- Colchicine
- Those who have a history of use of any PPIs, P-CABs or H2-receptor antagonists within recent 14 days prior to 13C-UBT of screening visit (Visit 1), or who need to take any of them during the study
- Those who have a history of use of bismuth or any antibiotics known to be effective at eradication of H. pylori within recent 28 days prior to 13C-UBT of screening visit (Visit 1), or who need to take any of them during the study
- For those using antibiotic resistance test results or samples prior to the screening visit (Visit 1), the subjects who have a history of antibiotic use from the time the results or samples were obtained (up to 90 days prior to the screening visit)
- Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Those to whom an upper GI endoscopy cannot be performed
- Pregnant or lactating women
- Those who do not agree to use a proper contraception throughout the study duration
- Proper contraception methods for the subject or his/her partner
- Sterilization (vasectomy, etc.), or intrauterine devices (copper loop, intrauterine systems containing hormones)
- Combined use of barrier methods with any one of non-oral hormonal contraceptives or spermicides
- Combined use of a cervical cap or contraceptive diaphragm with male condoms
- Those who have participated in other studies, and have been treated with the IP or medical device at least once within 4 weeks prior to participating in this study
- Those deemed ineligible to participate in this study based on the investigator's other medical opinions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- DWP14012 40mg, DWC202301 30mg, Amoxicillin 1000mg, Clarithromycin 500mg, DWC202301 30mg placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012 40mgDrug
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).
DWC202301 30mgDrug
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).
Amoxicillin 1000mgDrug
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).
Clarithromycin 500mgDrug
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 30mg placeboDrug
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 40mg placeboDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: DWC202301 30mg; Drug: Amoxicillin 1000mg; Drug: Clarithromycin 500mg; Drug: DWP14012 40mg placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate
- pylori eradication rate identified by 13C-UBT after at least 4 weeks (28 - 56 days) from the end of treatment
Measured: 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)
- pylori eradication rate identified by 13C-UBT after at least 4 weeks (28 - 56 days) from the end of treatment (for subjects who are resistant to clarithromycin)
Measured: 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)
- pylori eradication rate identified by 13C-UBT after at least 4 weeks (28- 56 days) from the end of treatment (for subjects who are not resistant to clarithromycin or amoxicillin)
Measured: after at least 4 weeks (28- 56 days) from the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start6 Feb 2024
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751121
- Sponsor's protocol ID
- DW_DWP14012310
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06751121
- Acronym / sponsor ID
- DW_DWP14012310
- Conditions
- Helicobacter Pylori Infection, Helicobacter Pylori Infected Patients, Helicobacter Pylori Infected Subjects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWP14012 40 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg | Experimental | Drug: DWP14012 40mg, Drug: Amoxicillin 1000mg, Drug: Clarithromycin 500mg, Drug: DWC202301 30mg placebo1 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 |
| DWC202301 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg | Active comparator | Drug: DWC202301 30mg, Drug: Amoxicillin 1000mg, Drug: Clarithromycin 500mg, Drug: DWP14012 40mg placebo1 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 |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
- Those who require treatment for H. pylori eradication as at least one of the following applies:
Key exclusion criteria (47 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DWP14012 40mgDWP14012 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 | DWP14012 40 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg |
| DWC202301 30mgDWC202301 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 | DWC202301 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg |
| Amoxicillin 1000mgAmoxicillin 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 | DWC202301 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg, DWP14012 40 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg |
| Clarithromycin 500mgClarithromycin 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 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg, DWP14012 40 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg |
| DWC202301 30mg placeboDWC202301 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 40 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg |
| DWP14012 40mg placeboDWP14012 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) | Drug | DWC202301 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg |
Primary outcome
H. pylori eradication rate
Time frame: after at least 4 weeks (28 - 56 days) from the end of treatment
H. pylori eradication rate identified by 13C-UBT after at least 4 weeks (28 - 56 days) from the end of treatment
2 secondary outcomes
H. pylori eradication rate(for subjects who are resistant to clarithromycin)
Time frame: 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)
Time frame: after at least 4 weeks (28- 56 days) from the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DWP14012 40mg, DWC202301 30mg and Amoxicillin 1000mg in people with Helicobacter Pylori Infection and Helicobacter Pylori Infected Patients, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. pylori eradication rate (time frame: after at least 4 weeks (28 - 56 days) from the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.