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

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

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

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Drug: JP-1366; Drug: JP-1366 placebo; Drug: Esomeprazole placebo; Drug: Esomeprazole 40mg

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital and 19 hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Onconic Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): December 11, 2020

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: JP-1366-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No