A Study to Evaluate the Effiacy and Safety of HIP0612 in Patients with Gastric Ulcer

A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of HIP0612 in Patients with Gastric Ulcer

A multicenter, randomized, double-blind, active-controlled, phase III study to evaluate the efficacy and safety of HIP0612 in patients with gastric ulcer.

Study Overview

• Status: Completed
• Conditions: Gastric Ulcer
• Intervention / Treatment: Drug: HIP0612; Drug: HPP2202; Drug: RLD2204; Drug: HPP2201

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 19 years to 75 years
• Diagnosis of active gastric ulcers according to the Sakita-Miwa classification from upper GI endoscopy
• Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

• Patients who cannot perform endoscopy
• Finding of malignancy, duodenal ulcer, ulcer perforation, postoperative (eg, endoscopic mucosal resection, endoscopic submucosal dissection) ulcer(s), Barrett's oesophagus measuring >3cm, oesophageal dysplasia, oesophageal and/or gastric varices, bleeding disorder on upper GI endoscopy
• History of definitive acid lowering surgery or pervious oesophageal or gastric surgery (except for benign tumor excisionn, simple close of perforations)
• Zollinger-Ellison syndrome, pyloric stenosis, oesophageal motility disorder, esophageal stricture
• Severe hepatic disease
• Severe renal disease, CKD
• Bleeding disorder
• History of malignancy or was treated for malignancy within 5 years before the start of the Visit 1
• Patients who have taken drugs containing following list within 2 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: acid suppressive drugs, antacids, anticholinergic drugs, gastroprotective agent
• Patients who have taken drugs containing following list within 1 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: antithrombotic agents, NSAIDs, aspirin
• Requirement of use of excluded medications during the study
• History of allergic reaction to the medications used in this study
• Glucose-galactose malabsorption, Fructose intolerance, Sucrase-isomaltase deficiency
• Use of other investigational drugs within 30 days prior to the study
• History of alcohol or drug abuse
• Positive to pregnancy test, nursing mother, intention on pregnancy
• Considered by investigator as not appropriate to participate in the clinical study with other reason

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIP0612; Taking HIP0612+HPP2202 once daily for 4 or 8 weeks.	Drug: HIP0612; Test drug; Drug: HPP2202; Placebo drug
Active Comparator: RLD2204; Taking RLD2204+HPP2201 once daily for 4 or 8 weeks.	Drug: RLD2204; Reference drug; Drug: HPP2201; Placebo drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing rate of gastric ulcer	Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study	week 8

Secondary Outcome Measures

Outcome Measure	Time Frame
Healing rate of gastric ulcer	week 4
Healing rate of gastric ulcer according to H.pylori infection status	week 4, 8
Post-treatment resolution rate of GI symptoms	week 4, 8

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): December 19, 2024
• Study Completion (Actual): December 19, 2024

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Duodenal Diseases; Peptic Ulcer; Ulcer; Stomach Ulcer
• Other Study ID Numbers: HM-AESOP-301

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
• product manufactured in and exported from the U.S.: No