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Not yet recruitingNCT07115173Updated Aug 14, 2025

Clinical Trial to Evaluate the Efficacy of Probit-Based Triple Therapy for Helicobacter Pylori Eradication

A Phase 4 interventional study of This study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of Zastaprazan 20 mg, clarithromycin, and amoxicillin for the eradication of Helicobacter pylori. in Helicobacter Infection, sponsored by Samsung Medical Center. Not yet recruiting. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by Samsung Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
103
Allocation
Not applicable
Ages
19 Years to 75 Years
Sex
All
01

Study summary

This is a single-center, open-label, non-randomized, single-arm clinical study. Eligible participants who provide written informed consent will undergo screening based on inclusion/exclusion criteria. Enrolled subjects will receive the investigational treatment: Zastaprazan 20 mg (twice daily), clarithromycin 500 mg (twice daily), and amoxicillin 1000 mg (three times daily) for 14 days. Four to eight weeks after completing the therapy, participants will return for a urea breath test to assess H. pylori eradication. The study will also investigate the efficacy of this therapy in clarithromycin-resistant patients to indirectly assess the potential of a dual regimen using Zastaprazan and amoxicillin.

02

Conditions studied

  • Helicobacter Infection
03

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female, aged 19 to 75 years at consent.
  2. Confirmed H. pylori positive by urease breath or enzyme test.
  3. Require eradication therapy due to at least one condition: chronic atrophic gastritis, peptic ulcer, history of early gastric cancer or adenoma resection, functional dyspepsia, low-grade MALT lymphoma, idiopathic thrombocytopenic purpura, iron deficiency anemia, hyperplastic polyps, or family history of gastric cancer.
  4. Agree to use medically acceptable contraception during the trial (including medically sterile women such as menopausal, hysterectomy, tubal ligation, or bilateral oophorectomy).
  5. Provide voluntary written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. History of receiving H. pylori eradication therapy prior to study participation.
  2. Known hypersensitivity to the investigational product, penicillin-class antibiotics, or macrolide-class antibiotics.
  3. Current use of medications contraindicated with the investigational product or concomitant therapy.
  4. Abnormal laboratory values in blood chemistry tests as defined by the protocol.
  5. pregnant or nursing women
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
103 participants (estimated)

Study arms

  • Experimental
    This study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of

    Drug: This study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of Zastaprazan 20 mg, clarithromycin, and amoxicillin for the eradication of Helicobacter pylori.

Interventions

  • DrugThis study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of Zastaprazan 20 mg, clarithromycin, and amoxicillin for the eradication of Helicobacter pylori.

    This study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of Zastaprazan 20 mg, clarithromycin, and amoxicillin for the eradication of Helicobacter pylori.

05

What researchers measure

Primary outcomes

  1. Eradication rate

    Efficacy of H. pylori eradication therapy. confirmed by negative UBT test

    Time frame: 4 to 8 weeks

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07115173
Lead sponsor
Samsung Medical Center
Responsible party
Sponsor
First posted
Aug 11, 2025
Start date
Dec 1, 2025 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 14, 2025

Study contacts

Byung-Hoon Min
Contact
jason.min@samsung.com
82-2-3410-3409

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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