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

PharmaKing1 site in 1 country88 target enrollmentNovember 24, 2014

ConditionsPeptic Ulcer

InterventionsPlacebo PMK-S005 1 PMK-S005 2 PMK-S005 3

DrugsPlacebo PMK-S005 1 PMK-S005 2 PMK-S005 3

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Peptic Ulcer
Sponsor: PharmaKing
Enrollment: 88
Locations: 1
Primary Endpoint: The incidence of endoscopic peptic ulcer
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 24, 2014

End Date

December 8, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

PharmaKing

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Placebo

Placebo Comparator / Bid

Intervention: Placebo

PMK-S005 1

Total 50mg, by mouth, bid

Intervention: PMK-S005 1

PMK-S005 2

Total 100mg, by mouth, bid

Intervention: PMK-S005 2

PMK-S005 3

Total 150mg, by mouth, bid

Intervention: PMK-S005 3

Outcomes

Primary Outcomes

The incidence of endoscopic peptic ulcer

Time Frame: 12 weeks

Secondary Outcomes

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)
The incidence of endoscopic stomach / duodenal mucosal disease(erosion, ulcer)(12 weeks)
The incidence of endoscopic stomach / duodenal ulcer(12 weeks)
The incidence of endoscopic stomach / duodenal erosion(12 weeks)