Efficacy and Safety of PMK-S005 in the Prevention of Recurrent Peptic Ulcer in Low-dose Aspirin Users

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety by comparing prevention of recurrent peptic ulcer in low-dose aspirin users between PMK-S005 and Placebo.

Official Title
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A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled, Dose-finding, Phase IIa Clinical Trial to Efficacy and Safety of PMK-S005 for the Prevention of Recurrent Peptic Ulcer in Low-dose Aspirin Users

Conditions
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Peptic Ulcer

Intervention / Treatment
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* Drug: Placebo
* Drug: PMK-S005 1
* Drug: PMK-S005 2
* Drug: PMK-S005 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female over 19 years of age Accompanied by hypertension, diabetes, ischemic heart disease, arrhythmia, dyslipidemia patients who are required to continuous administration of low-dose aspirin(100mg) Patients who get Modified Lanza Score (MLS) 0 in screening period according to endoscopic findings Patients who have stomach or duodenal ulcer scar in screening period according to endoscopic findings. But, the cases that scars caused by other disorders or endoscopic treatment are excluded Patients who have no digestive symptoms(except for mild physconia, abdominal pain, diarrhea and vomit, nausea-vomiting) in screening period Signature of the written informed consent Exclusion Criteria: Within 4 weeks prior to screening period, patients who continuously take aspirin or NSAIDs Patient who has hypersensitivity to PMK-S005 and aspirin components or is banned to use them Patients who had a abdominal surgery that affect gastrointestinal motility (Except appendectomy and hysterectomy), But, patients who had enterectomy is excluded regardless of the time period Patients who are judged by investigator that they have other upper gastroesophageal disease, active/healing-stage peptic ulcer, digestive malignant tumor or Barrett's esophagus Patients with Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), Ulcerative Colitis, Crohn's disease, Zolinger-Ellison syndrome History of esophagus, liver, pancreas, stomach, colorectal cancer or malignant tumors within 5 years History of malabsorption within 3 months prior to screening period Patients who have been taken drug that affect the validity within 2 weeks before beginning of the clinical test Patient who is needed continuously to take antithrombotic agents , anti- coagulant , anti- choline agents, prostaglandins , mucosal protective agents , methotrexate, antidepressants , iron treat agents during clinical test. Patients with clinical meaningful laboratory test results Known alcohol and/or any other drug abuse or dependence Pregnant or lactating women Women planning to become pregnant Within 1 month, patients who have been taken other clinical test drug Patients who are judged by investigator that participation of the study is difficult

Ages Eligible for Study
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Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo Comparator / Bid | Drug: Placebo<br>* Drug : Placebo<br>|
| Experimental: PMK-S005 1<br>Total 50mg, by mouth, bid | Drug: PMK-S005 1<br>* Drug : PMK-S005 1 (50mg)<br>|
| Experimental: PMK-S005 2<br>Total 100mg, by mouth, bid | Drug: PMK-S005 2<br>* Drug : PMK-S005 2 (100mg)<br>|
| Experimental: PMK-S005 3<br>Total 150mg, by mouth, bid | Drug: PMK-S005 3<br>* Drug : PMK-S005 3 (150mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of endoscopic peptic ulcer |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of endoscopic stomach / duodenal mucosal disease(erosion, ulcer) |  | 12 weeks | 
| The incidence of endoscopic stomach / duodenal erosion |  | 12 weeks | 
| The incidence of endoscopic stomach / duodenal ulcer |  | 12 weeks | 
| The changes of MLS in the gastroduodenal endoscopy result compared to baseline |  | 12 weeks | 
| The incidence of endoscopic esophagitis |  | 16 weeks | 
| Rescue drug use count and the total amount |  | 16 weeks | 
| Changes in gastrointestinal symptoms score |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, Recurrent peptic ulcer