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NCT04282954 Clinical Trial

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

GERD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04282954
Other study ID # JP-1366-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 15, 2019
Est. completion date December 11, 2020

Study information
Verified date July 2022
Source Onconic Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 188
Est. completion date December 11, 2020
Est. primary completion date October 20, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• JP-1366
JP-1366, QD
• JP-1366 placebo
JP-1366 placebo, QD
• Esomeprazole 40mg
Esomeprazole 40mg, QD
• Esomeprazole placebo
Esomeprazole placebo, QD

Locations
Country Name City State
Korea, Republic of Severance Hospital and 19 hospitals Seoul

Sponsors (1)
Lead Sponsor Collaborator
Onconic Therapeutics Inc.

Country where clinical trial is conducted

Korea, Republic of, 

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