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

PharmaKing

Status and phase: Completed; Phase 2

Conditions: Peptic Ulcer

Treatments: Drug: PMK-S005 2; Drug: PMK-S005 3; Drug: Placebo; Drug: PMK-S005 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02342470

PMK-S005_Phase II

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo Comparator / Bid

Treatment:

Drug: Placebo

PMK-S005 1

Experimental group

Description:

Total 50mg, by mouth, bid

Treatment:

Drug: PMK-S005 1

PMK-S005 2

Experimental group

Description:

Total 100mg, by mouth, bid

Treatment:

Drug: PMK-S005 2

PMK-S005 3

Experimental group

Description:

Total 150mg, by mouth, bid

Treatment:

Drug: PMK-S005 3