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

Primary Purpose

Peptic Ulcer

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Placebo

PMK-S005 1

PMK-S005 2

PMK-S005 3

About this trial

This is an interventional prevention trial for Peptic Ulcer focused on measuring prevention, Recurrent peptic ulcer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Bundang Seoul University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

PMK-S005 1

PMK-S005 2

PMK-S005 3

Arm Description

Placebo Comparator / Bid

Total 50mg, by mouth, bid

Total 100mg, by mouth, bid

Total 150mg, by mouth, bid

Outcomes

Primary Outcome Measures

The incidence of endoscopic peptic ulcer

Secondary Outcome Measures

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

The incidence of endoscopic stomach / duodenal erosion

The incidence of endoscopic stomach / duodenal ulcer

The changes of MLS in the gastroduodenal endoscopy result compared to baseline

The incidence of endoscopic esophagitis

Rescue drug use count and the total amount

Changes in gastrointestinal symptoms score

Full Information

NCT ID

NCT02342470

First Posted

December 19, 2014

Last Updated

January 20, 2018

Sponsor

PharmaKing

1. Study Identification

Unique Protocol Identification Number

NCT02342470

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

November 24, 2014 (Actual)

Primary Completion Date

December 8, 2017 (Actual)

Study Completion Date

December 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PharmaKing

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peptic Ulcer

Keywords

prevention, Recurrent peptic ulcer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo Comparator / Bid

Arm Title

PMK-S005 1

Arm Type

Experimental

Arm Description

Total 50mg, by mouth, bid

Arm Title

PMK-S005 2

Arm Type

Experimental

Arm Description

Total 100mg, by mouth, bid

Arm Title

PMK-S005 3

Arm Type

Experimental

Arm Description

Total 150mg, by mouth, bid

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Drug : Placebo

Intervention Type

Drug

Intervention Name(s)

PMK-S005 1

Intervention Description

Drug : PMK-S005 1 (50mg)

Intervention Type

Drug

Intervention Name(s)

PMK-S005 2

Intervention Description

Drug : PMK-S005 2 (100mg)

Intervention Type

Drug

Intervention Name(s)

PMK-S005 3

Intervention Description

Drug : PMK-S005 3 (150mg)

Primary Outcome Measure Information:

Title

The incidence of endoscopic peptic ulcer

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Title

The incidence of endoscopic stomach / duodenal erosion

Time Frame

12 weeks

Title

The incidence of endoscopic stomach / duodenal ulcer

Time Frame

12 weeks

Title

The changes of MLS in the gastroduodenal endoscopy result compared to baseline

Time Frame

12 weeks

Title

The incidence of endoscopic esophagitis

Time Frame

16 weeks

Title

Rescue drug use count and the total amount

Time Frame

16 weeks

Title

Changes in gastrointestinal symptoms score

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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 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

Facility Information:

Facility Name

Bundang Seoul University Hospital

City

Gumi-dong

State/Province

Bundang-gu, Seongnam-si, Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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