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

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

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

Conditions
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Gastric Ulcer

Intervention / Treatment
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* Drug: HIP0612
* Drug: HPP2202
* Drug: RLD2204
* Drug: HPP2201


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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 |