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CompletedNCT04282954Updated Jul 13, 2022

Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease

A Phase 2 interventional study of JP-1366 and JP-1366 placebo in GERD, sponsored by Onconic Therapeutics Inc.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-13.

Sponsored by Onconic Therapeutics Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2019, registered Feb 2020).
Phase
Phase 2
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study summary

Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease

02

Conditions studied

  • GERD
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 188 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Onconic Therapeutics Inc. is the lead sponsor of 18 studies on the registry; 8 are open to participants now.

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

Inclusion criteria

  • Adults between 19 and 75 years old based on the date of written agreement
  • Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
  • Those who experienced symptoms of heartburn or acid reflux within the last 7 days

Exclusion criteria

Exclusion Criteria:

  • Those who have undergone gastric acid suppression or gastric, esophageal surgery
  • Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
  • Clinically significant abnormal laboratory values during screening
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
188 participants (actual)

Study arms

  • Experimental
    Group 1

    JP-1366 A mg

    Drug: JP-1366 · Drug: JP-1366 placebo · Drug: Esomeprazole placebo

  • Experimental
    Group 2

    JP-1366 B mg

    Drug: JP-1366 · Drug: JP-1366 placebo · Drug: Esomeprazole placebo

  • Experimental
    Group 3

    JP-1366 C mg

    Drug: JP-1366 · Drug: JP-1366 placebo · Drug: Esomeprazole placebo

  • Active comparator
    Goup 4

    Esomeprazole 40 mg

    Drug: JP-1366 placebo · Drug: Esomeprazole 40mg

Interventions

  • DrugJP-1366

    JP-1366, QD

  • DrugJP-1366 placebo

    JP-1366 placebo, QD

  • DrugEsomeprazole 40mg

    Esomeprazole 40mg, QD

  • DrugEsomeprazole placebo

    Esomeprazole placebo, QD

06

What researchers measure

Primary outcomes

  1. Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%)

    \* Erosion recovered to normal mucous membrane on upper gastrointestinal endoscopy

    Time frame: 8 weeks

07

Study locations

1 site
  • Severance Hospital and 19 hospitals
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04282954
Lead sponsor
Onconic Therapeutics Inc.
Responsible party
Sponsor
First posted
Feb 25, 2020
Start date
Nov 15, 2019
Primary completion
Oct 20, 2020
Completion
Dec 11, 2020
Last update
Jul 13, 2022

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 completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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