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

NCT ID: NCT05656092

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2024-12-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HIP0612

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

Group Type: EXPERIMENTAL

HIP0612

Intervention Type: DRUG

Test drug

HPP2202

Intervention Type: DRUG

Placebo drug

RLD2204

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

Group Type: ACTIVE_COMPARATOR

RLD2204

Intervention Type: DRUG

Reference drug

HPP2201

Intervention Type: DRUG

Placebo drug

Interventions

HIP0612

Test drug

Intervention Type: DRUG

HPP2202

Placebo drug

Intervention Type: DRUG

RLD2204

Reference drug

Intervention Type: DRUG

HPP2201

Placebo drug

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HM-AESOP-301

Identifier Type: -

Identifier Source: org_study_id