HELICOBACTER PYLORI INFECTIONSNCT07855497
Efficacy and Safety of Second-Line Helicobacter Pylori Eradication
A study testing P-CAB-BM quadruple regimen and Moxifloxacin triple regimen in people with HELICOBACTER PYLORI INFECTIONS, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Subjects with persistent H. pylori infection after first-line treatment failure receives either a 14-day PPI-based moxifloxacin triple regimen (esomeprazole, amoxicillin, and moxifloxacin) or a 14-day P-CAB-bismuth-containing moxifloxacin quadruple regimen (tegoprazan, amoxicillin, moxifloxacin, and bismuth). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- P-CAB-BM quadruple regimen and Moxifloxacin triple regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2021to 28 Sep 2027
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with persistent H. pylori infection after failure of first-line eradication therapy
- H. pylori infection was confirmed by at least one positive result on the 13C-urea breath test (UBT), rapid urease test, or histology
- Patients who provided written informed consent and who are able to complete symptom questionnaires
Who cannot join
- Individuals younger than 19 years, pregnant or lactating females, patients with previous total gastrectomy, severe systemic diseases, recent use of antibiotics or acid-suppressive medications, drug allergies, or other conditions considered inappropriate by the investigators
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Efficacy and Safety of Potassium-Competitive Acid Blocker-Bismuth Quadruple Therapy for Second-Line Helicobacter Pylori Eradication
Subjects with persistent H. pylori infection after first-line treatment failure receives either a 14-day PPI-based moxifloxacin triple regimen (esomeprazole, amoxicillin, and moxifloxacin) or a 14-day P-CAB-bismuth-containing moxifloxacin quadruple regimen (tegoprazan, amoxicillin, moxifloxacin, and bismuth).
Read the detailed description
Participants with confirmed failure of first-line H. pylori eradication therapy are randomly assigned to receive either P-CAB and BM-containing moxifloxacin quadruple therapy (tegoprazan 50 mg twice daily, amoxicillin 500 mg four times daily, moxifloxacin 400 mg once daily, and tripotassium dicitrate BM 300 mg four times daily; P-CAB-BM quad regimen) or conventional PPI-based moxifloxacin triple therapy (esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, and moxifloxacin 400 mg once daily; moxifloxacin triple regimen) for 14 days.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- P-CAB-BM quadruple regimen, Moxifloxacin triple regimen
- Keywords
- HELICOBACTER PYLORI, Moxifloxacin, Bismuth, Sex differences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-CAB-BM quadruple regimenDrug
Also called Esomeprazole, amoxicillin, and moxifloxacin regimen
Esomeprazole, amoxicillin, and moxifloxacin
Moxifloxacin triple regimenDrug
Also called Tegoprazan, amoxicillin, moxifloxacin, and bismuth regimen
Tegoprazan, amoxicillin, moxifloxacin, and bismuth
| Study group | Role | What they receive |
|---|---|---|
| P-CAB-BM quad | Experimental | 14-day PPI-based moxifloxacin triple regimen (esomeprazole, amoxicillin, and moxifloxacin) Receives: Drug: P-CAB-BM quadruple regimen |
| Moxifloxacin triple | Active comparator | 14-day P-CAB-bismuth-containing moxifloxacin quadruple regimen (tegoprazan, amoxicillin, moxifloxacin, and bismuth) Receives: Drug: Moxifloxacin triple regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of H. pylori eradication
Success rate of H. pylori eradication of each regimen (ITT and PP)
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (1)
Adverse events
Adverse events of each regimen
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Feb 2021
- Primary completion28 Sep 2026
- Study completion28 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with confirmed failure of first-line H. pylori eradication therapy are randomly assigned to receive either P-CAB and BM-containing moxifloxacin quadruple therapy (tegoprazan 50 mg twice daily, amoxicillin 500 mg four times daily, moxifloxacin 400 mg once daily, and tripotassium dicitrate BM 300 mg four times daily; P-CAB-BM quad regimen) or conventional PPI-based moxifloxacin triple ther- apy (esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, and moxifloxacin 400 mg once daily; moxifloxacin triple regimen) for 14 days.
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
- Investigators
- Nayoung Kim, M.D., Ph.D., Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855497
- Sponsor's protocol ID
- B-2011-649-004
- Other IDs
- 2025-ER1104-01
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No