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Not yet recruitingNCT07875933Updated Oct 15, 2026

Efficacy and Safety of JP-1366-based Triple Therapy in Helicobacter Pylori-positive Subjects

A Phase 3 interventional study of JP-1366 20 mg, Lansoprazole 30 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg and Lansoprazole 30mg, JP-1366 20 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg in H. Pylori Eradication Therapy, sponsored by Onconic Therapeutics Inc.. Not yet recruiting. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Onconic Therapeutics Inc. (part of Jeil Pharmaceutical Co., Ltd.) · Phase 3, Interventional, and Treatment

Updated Oct 15, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
414
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study summary

This study aims to evaluate the Efficacy and Safety of JP-1366-based Triple-Therapy in H. pylori-positive Subjects

Read the detailed description

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Non-inferiority, Phase III Study

02

Conditions studied

  • H. Pylori Eradication Therapy

Keywords

  • H. pylori
03

In context

Lead sponsor

Onconic Therapeutics Inc. is the lead sponsor of 19 studies on the registry; 9 are open to participants now.

Browse Onconic Therapeutics Inc. studies →All Jeil Pharmaceutical Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult males or females aged ≥19 years and ≤75 years at the time of written informed consent
  2. Participants with a confirmed positive result for 13C-UBT performed at the Screening Visit (Visit 1)
  3. Participants with a confirmed positive result for H. pylori in the CLO test performed at the Screening Visit (Visit 1) (If test results obtained at the same study site within 12 weeks prior to the Screening Visit (Visit 1) are available, those results may be used.)

Exclusion criteria

Exclusion Criteria:

  1. Participants diagnosed with significant acute upper gastrointestinal bleeding within 4 weeks prior to the Screening Visit (Visit 1)
  2. Participants with a procedural history that affects gastric acid secretion (partial gastrectomy, vagotomy, etc.) prior to the Screening Visit (Visit 1)
  3. Participants with Zollinger-Ellison syndrome or other hyperchlorhydria disorders at the Screening Visit (Visit 1)
  4. Participants who have had H. pylori eradication therapy at least once before the Screening Visit (Visit 1)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
414 participants (estimated)

Study arms

  • Experimental
    Experimental Group

    Drug: JP-1366 20 mg, Lansoprazole 30 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg

  • Active comparator
    Active Comparative Group

    Drug: Lansoprazole 30mg, JP-1366 20 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg

Interventions

  • DrugJP-1366 20 mg, Lansoprazole 30 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg

    Orally, twice daily

  • DrugLansoprazole 30mg, JP-1366 20 mg Placebo, Clarithromycin 500mg, Amoxicillin 1000mg

    Orally, twice daily

06

What researchers measure

Primary outcomes

  1. H. pylori eradication rate after a minimum of 4 weeks from completion of Investigational product administration

    Time frame: at least 4 weeks after completion of administration

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Sep 2028, 22 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2026
First posted
Oct 15, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Sep 6, 2028
CompletionEst.
Oct 6, 2028
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07875933
Lead sponsor
Onconic Therapeutics Inc.
Responsible party
Sponsor
First posted
Oct 15, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Sep 6, 2028 (estimated)
Completion
Oct 6, 2028 (estimated)
Last update
Oct 15, 2026

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 Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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