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

NCT05656092 | Completed Phase 3

• 1 other identifier: HM-AESOP-301
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

HIP0612

EXPERIMENTAL

Taking HIP0612+HPP2202 once daily for 4 or 8 weeks.

Drug: HIP0612; Drug: HPP2202

RLD2204

ACTIVE COMPARATOR

Taking RLD2204+HPP2201 once daily for 4 or 8 weeks.

Drug: RLD2204; Drug: HPP2201

Interventions

HIP0612 DRUG

Test drug

HIP0612

HPP2202 DRUG

Placebo drug

HIP0612

RLD2204 DRUG

Reference drug

RLD2204

HPP2201 DRUG

Placebo drug

RLD2204

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Ulcer

Condition Hierarchy (Ancestors)

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

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: December 9, 2022
• First Posted: December 19, 2022
• Study Start: March 6, 2023
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)