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

Primary Purpose

GERD

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
JP-1366
JP-1366 placebo
Esomeprazole 40mg
Esomeprazole placebo
Sponsored by
Onconic Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GERD

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Severance Hospital and 19 hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Goup 4

Arm Description

JP-1366 A mg

JP-1366 B mg

JP-1366 C mg

Esomeprazole 40 mg

Outcomes

Primary Outcome Measures

Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%)
* Erosion recovered to normal mucous membrane on upper gastrointestinal endoscopy

Secondary Outcome Measures

Full Information

First Posted
February 21, 2020
Last Updated
July 11, 2022
Sponsor
Onconic Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04282954
Brief Title
Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease
Official Title
A Randomized, Double-blind, Active-controlled, Multi-center Phase II Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
October 20, 2020 (Actual)
Study Completion Date
December 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Onconic Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
JP-1366 A mg
Arm Title
Group 2
Arm Type
Experimental
Arm Description
JP-1366 B mg
Arm Title
Group 3
Arm Type
Experimental
Arm Description
JP-1366 C mg
Arm Title
Goup 4
Arm Type
Active Comparator
Arm Description
Esomeprazole 40 mg
Intervention Type
Drug
Intervention Name(s)
JP-1366
Intervention Description
JP-1366, QD
Intervention Type
Drug
Intervention Name(s)
JP-1366 placebo
Intervention Description
JP-1366 placebo, QD
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 40mg
Intervention Description
Esomeprazole 40mg, QD
Intervention Type
Drug
Intervention Name(s)
Esomeprazole placebo
Intervention Description
Esomeprazole placebo, QD
Primary Outcome Measure Information:
Title
Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%)
Description
* Erosion recovered to normal mucous membrane on upper gastrointestinal endoscopy
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Facility Information:
Facility Name
Severance Hospital and 19 hospitals
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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