Peptic Ulcer
Conditions
Keywords
prevention, Recurrent peptic ulcer
Brief 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.
Interventions
DRUGPlacebo
Drug : Placebo
DRUGPMK-S005 1
Drug : PMK-S005 1 (50mg)
DRUGPMK-S005 2
Drug : PMK-S005 2 (100mg)
DRUGPMK-S005 3
Drug : PMK-S005 3 (150mg)
Sponsors
PharmaKing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of endoscopic peptic ulcer | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 stomach / duodenal mucosal disease(erosion, ulcer) | 12 weeks |
| Rescue drug use count and the total amount | 16 weeks |
| Changes in gastrointestinal symptoms score | 16 weeks |
| The incidence of endoscopic esophagitis | 16 weeks |
Countries
South Korea
Outcome results
None listed