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

• Status: Completed
• Trial end date: 2017-12-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaKing
• Treatments: Aspirin

Criteria

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