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

Sponsor

Onconic Therapeutics Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04282954

Collaborator

(none)

188

Enrollment

Location

Arms

12.9

Actual Duration (Months)

14.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
GERD	Drug: JP-1366 Drug: JP-1366 placebo Drug: Esomeprazole 40mg Drug: Esomeprazole placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

188 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 15, 2019

Actual Primary Completion Date :

Oct 20, 2020

Actual Study Completion Date :

Dec 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 JP-1366 A mg	Drug: JP-1366 JP-1366, QD Drug: JP-1366 placebo JP-1366 placebo, QD Drug: Esomeprazole placebo Esomeprazole placebo, QD
Experimental: Group 2 JP-1366 B mg	Drug: JP-1366 JP-1366, QD Drug: JP-1366 placebo JP-1366 placebo, QD Drug: Esomeprazole placebo Esomeprazole placebo, QD
Experimental: Group 3 JP-1366 C mg	Drug: JP-1366 JP-1366, QD Drug: JP-1366 placebo JP-1366 placebo, QD Drug: Esomeprazole placebo Esomeprazole placebo, QD
Active Comparator: Goup 4 Esomeprazole 40 mg	Drug: JP-1366 placebo JP-1366 placebo, QD Drug: Esomeprazole 40mg Esomeprazole 40mg, QD

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital and 19 hospitals	Seoul		Korea, Republic of

Sponsors and Collaborators

Onconic Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Onconic Therapeutics Inc.

ClinicalTrials.gov Identifier:

NCT04282954

Other Study ID Numbers:

JP-1366-201

First Posted:

Feb 25, 2020

Last Update Posted:

Jul 13, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastroesophageal Reflux

Esomeprazole

Study Results

No Results Posted as of Jul 13, 2022