Clinical Trial to Evaluate the Efficacy and Safety of JP-1366 in Patients With Gastric Ulcer

NCT05448001 | Completed Phase 3

• 1 other identifier: JP-1366-303
• Study Type: interventional
• Target: 329
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Ulcer

Outcome Measures

Primary Outcomes (1)

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

  Week 8

Secondary Outcomes (7)

• Complete healing rate for ulcers confirmed by upper gastrointestinal endoscopy at Week 4

  Week 4

• Complete healing rate for ulcer confirmed by upper gastrointestinal endoscopy at Week 4 by Helicobacter pylori infection status

  Week 4

• Cumulative complete healing rate for ulcer confirmed by upper gastrointestinal endoscopy according to Helicobacter pylori infection status by Week 8

  Week 8

• Changes of Gastrointestinal symptoms per NDI-K at week 4 and 8

  Week 4 and 8

• Changes in quality of life (EQ-5D-5L) at Weeks 4 and 8

  Week 4 and 8

Other Outcomes (1)

• Exploratory Endpoints

  2weeks after the end of treatment

Study Arms (2)

Study Group

EXPERIMENTAL

Drug: JP-1366 20mg

Control Group

ACTIVE COMPARATOR

Drug: Lansoprazole 30mg

Interventions

JP-1366 20mg DRUG

JP-1366 20 mg 1 capsule, Lansoprazole 30 mg placebo 1 capsule before meal

Study Group

Lansoprazole 30mg DRUG

JP-1366 20 mg placebo 1 capsule, Lansoprazole 30 mg 1 capsule before meal

Control Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \[Medical History\]
• 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 1.
• Subjects who have had or are scheduled to have major surgery that may affect gastric acid secretion within 30 days from Visit 1
• \[Comorbidity\]
• Subjects with gastrointestinal bleeding, esophageal stricture, ulcer-induced stenosis, pyloric stenosis, gastroesophageal varices, Barrett's esophagus (\> 3 cm), esophageal dysplasia, duodenal ulcer, glandular ulcer, refractory ulcer, perforation ulcer, or surgery-induced ulcer at Visit 1
• Subjects with signal symptoms (dysphagia, severe dysphagia, bleeding, weight loss, anemia, and bloody stools) that suggest malignant tumors of gastrointestinal tract at Visit 1 (except a tumor confirmed negative in endoscopy, etc.)
• Subjects with pancreatitis, inflammatory bowel Disease (Crohn's disease, ulcerative colitis, or Behcet's enteritis) at Visit 1
• Subjects with known acquired immune deficiency syndrome (AIDS) or hepatitis (including Hepatitis B surface (HBs) antigen positive, Hepatitis C virus (HCV) antibody positive, or hepatitis virus carrier) (except subjects that are HCV-RNA negative)
• Subject with clinically significant mental illness
• Thrombotic patients (cerebral thrombosis, myocardial infarction, thrombophlebitis, etc.)

Sponsors & Collaborators

• Onconic Therapeutics Inc.: lead

Study Sites (1)

Korea University Kuro Hospital

Seoul, South Korea

Location

Related Publications (1)

• Park KS, Kim HS, Oh JH, Chung WC, Choi SC, Lee SH, Kim TH, Cheung DY, Baik GH, Kim SM, Lee HL, Moon JS, Choi CW, Sohn C, Kim KO, Kim BW, Jung HK, Jung DH, Kim SS, Park MI, Lee JY, Kim GH, Moon HS, Chun H, Shim KN, Shin WG, Park CH, Kim T, Jung SW, Kim H, Jee SR, Lee K, Cho YK, Park SC, Cho J, Huh C, Kwon H, Kim J, Kim J, Park JJ. Randomized, Double-Blind, Active-Controlled, Parallel, Phase 3 Clinical Trial for Evaluating the Efficacy and Safety of Zastaprazan in Patients with Gastric Ulcers. Gut Liver. 2026 Jan 16. doi: 10.5009/gnl250334. Online ahead of print.

  PMID: 41540828 DERIVED

MeSH Terms

Conditions

Stomach Ulcer

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 7, 2022
• Study Start: September 19, 2022
• Primary Completion: July 10, 2024
• Study Completion: July 19, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

KR (1)