A Multi-center, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 in Patients With Gastric Ulcer

Onconic Therapeutics Inc.1 site in 1 country329 target enrollmentSeptember 19, 2022

ConditionsGastric Ulcer

InterventionsLansoprazole 30mg JP-1366 20mg

Overview

Phase: Phase 3
Intervention: Lansoprazole 30mg
Conditions: Gastric Ulcer
Sponsor: Onconic Therapeutics Inc.
Enrollment: 329
Locations: 1
Primary Endpoint: Cumulative complete healing rate for ulcer confirmed by upper gastrointestinal endoscopy by Week 8
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Multi-center, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 in Patients with Gastric Ulcer

Registry

clinicaltrials.gov

Start Date

September 19, 2022

End Date

July 19, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Onconic Therapeutics Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who meet all of the following criteria can participate in this study:
•Male or female, ≥ 19 years of age at the time of obtaining consent
•Confirmation via upper gastrointestinal endoscopy within 14 days from Visit 2 for the following:
•º One or more GUs with the largest ulcer ≥ 3 mm to ≤ 30 mm
•º Largest ulcer classified as A1 or A2 based on Sakita-Miwa classification
•Subjects who fully understand this study and voluntarily signed the informed consent form

Exclusion Criteria

•Subjects who meet any of the following criteria cannot participate in this trial:
•\[Medical History\]
•Subjects who have undergone gastric acid secretion suppression surgery, gastric surgery (e.g., gastrectomy and gastromucosectomy), resection of entire small bowel (excluding simple ulcer closure and endoscopic benign tumor resection) or esophageal surgery
•Subjects with history of Zollinger-Ellison syndrome or gastric hypersecretion
•Subjects with hypersensitivity (present or past) to any substance in the IP, drugs in the same class as them (potassium-competitive acid blocker \[P-CAB\] and proton pump ingibitor\[PPI\]), or benzimidazole
•Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
•Subjects with malignant gastrointestinal cancer regardless of the period, Subjects with a history of malignancy within 5 years from Visit 1 (however, subjects with basal cell carcinoma or squamous cell carcinoma who require steady long-term follow-up only without therapeutic dosing/procedure/surgery, etc. can participate in this trial)
•Subjects with a history of drug or alcohol abuse within 1 year from Visit
•Subjects who have had or are scheduled to have major surgery that may affect gastric acid secretion within 30 days from Visit 1
•\[Comorbidity\]

Arms & Interventions

Control Group

Intervention: Lansoprazole 30mg

Study Group

Intervention: JP-1366 20mg

Outcomes

Primary Outcomes

Cumulative complete healing rate for ulcer confirmed by upper gastrointestinal endoscopy by Week 8

Time Frame: Week 8

Secondary Outcomes

Complete healing rate for ulcers confirmed by upper gastrointestinal endoscopy at Week 4(Week 4)
Changes and the proportion of changes of the ulcer size(s) at week 4 and week 8(Week 4 and 8)
Change of the number of ulcer(s) at week 4 and week 8(Week 4 and 8)
Cumulative complete healing rate for ulcer confirmed by upper gastrointestinal endoscopy according to Helicobacter pylori infection status by Week 8(Week 8)
Complete healing rate for ulcer confirmed by upper gastrointestinal endoscopy at Week 4 by Helicobacter pylori infection status(Week 4)
Changes in quality of life (EQ-5D-5L) at Weeks 4 and 8(Week 4 and 8)
Changes of Gastrointestinal symptoms per NDI-K at week 4 and 8(Week 4 and 8)