Efficacy and Safety of PMK-S005 in the Prevention of Recurrent Peptic Ulcer in Low-dose Aspirin Users
NCT ID: NCT02342470
Last Updated: 2018-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
88 participants
INTERVENTIONAL
2014-11-24
2017-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo
Placebo Comparator / Bid
Placebo
Drug : Placebo
PMK-S005 1
Total 50mg, by mouth, bid
PMK-S005 1
Drug : PMK-S005 1 (50mg)
PMK-S005 2
Total 100mg, by mouth, bid
PMK-S005 2
Drug : PMK-S005 2 (100mg)
PMK-S005 3
Total 150mg, by mouth, bid
PMK-S005 3
Drug : PMK-S005 3 (150mg)
Interventions
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Placebo
Drug : Placebo
PMK-S005 1
Drug : PMK-S005 1 (50mg)
PMK-S005 2
Drug : PMK-S005 2 (100mg)
PMK-S005 3
Drug : PMK-S005 3 (150mg)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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PharmaKing
INDUSTRY
Responsible Party
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Locations
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Bundang Seoul University Hospital
Kumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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PMK-S005_Phase II
Identifier Type: -
Identifier Source: org_study_id
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