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

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

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.

Study Overview

• Status: Completed
• Conditions: Peptic Ulcer
• Intervention / Treatment: Drug: Placebo; Drug: PMK-S005 1; Drug: PMK-S005 2; Drug: PMK-S005 3

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang-gu, Seongnam-si, Gyeonggi-do
    • Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Bundang Seoul University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo Comparator / Bid	Drug: Placebo; Drug : Placebo
Experimental: PMK-S005 1; Total 50mg, by mouth, bid	Drug: PMK-S005 1; Drug : PMK-S005 1 (50mg)
Experimental: PMK-S005 2; Total 100mg, by mouth, bid	Drug: PMK-S005 2; Drug : PMK-S005 2 (100mg)
Experimental: PMK-S005 3; Total 150mg, by mouth, bid	Drug: PMK-S005 3; Drug : PMK-S005 3 (150mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of endoscopic peptic ulcer	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of endoscopic stomach / duodenal mucosal disease(erosion, ulcer)	12 weeks
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 esophagitis	16 weeks
Rescue drug use count and the total amount	16 weeks
Changes in gastrointestinal symptoms score	16 weeks

Collaborators and Investigators

• Sponsor: PharmaKing

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2014
• Primary Completion (Actual): December 8, 2017
• Study Completion (Actual): December 8, 2017

Study Registration Dates

• First Submitted: December 19, 2014
• First Submitted That Met QC Criteria: January 14, 2015
• First Posted (Estimate): January 21, 2015

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 20, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: prevention; Recurrent peptic ulcer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Ulcer; Peptic Ulcer
• Other Study ID Numbers: PMK-S005_Phase II