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

Phase 2

Completed

• Conditions: GERD
• Interventions: Drug: JP-1366; Drug: Esomeprazole 40mg; Drug: JP-1366 placebo; Drug: Esomeprazole placebo

• Registration Number: NCT04282954
• Lead Sponsor: Onconic Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-15
• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-25
• Primary Completion: 2020-10-20
• Study Completion: 2020-12-11
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Esomeprazole placebo	JP-1366 B mg
Goup 4	Esomeprazole 40mg	Esomeprazole 40 mg
Group 2	JP-1366 placebo	JP-1366 B mg
Group 1	JP-1366 placebo	JP-1366 A mg
Group 3	Esomeprazole placebo	JP-1366 C mg
Group 1	Esomeprazole placebo	JP-1366 A mg
Goup 4	JP-1366 placebo	Esomeprazole 40 mg
Group 3	JP-1366	JP-1366 C mg
Group 3	JP-1366 placebo	JP-1366 C mg
Group 1	JP-1366	JP-1366 A mg
Group 2	JP-1366	JP-1366 B mg

Primary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital and 19 hospitals; 🇰🇷 Seoul, Korea, Republic of