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

Phase 3

Completed

• Conditions: Gastric Ulcer
• Interventions: Drug: HIP0612; Drug: RLD2204; Drug: HPP2202; Drug: HPP2201

• Registration Number: NCT05656092
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-09
• Study First Posted: 2022-12-19
• Study Start: 2023-03-06
• Primary Completion: 2024-12-19
• Study Completion: 2024-12-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIP0612	HIP0612	Taking HIP0612+HPP2202 once daily for 4 or 8 weeks.
HIP0612	HPP2202	Taking HIP0612+HPP2202 once daily for 4 or 8 weeks.
RLD2204	RLD2204	Taking RLD2204+HPP2201 once daily for 4 or 8 weeks.
RLD2204	HPP2201	Taking RLD2204+HPP2201 once daily for 4 or 8 weeks.

Primary Outcome Measures

Name	Time	Method
Healing rate of gastric ulcer	week 8	Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of