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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02342470
Other study ID # PMK-S005_Phase II
Secondary ID
Status Completed
Phase Phase 2
First received December 19, 2014
Last updated January 20, 2018
Start date November 24, 2014
Est. completion date December 8, 2017

Study information

Verified date January 2018
Source PharmaKing
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date December 8, 2017
Est. primary completion date December 8, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
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)

Locations

Country Name City State
Korea, Republic of Bundang Seoul University Hospital Gumi-dong Bundang-gu, Seongnam-si, Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
PharmaKing

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of endoscopic peptic ulcer 12 weeks
Secondary The incidence of endoscopic stomach / duodenal mucosal disease(erosion, ulcer) 12 weeks
Secondary The incidence of endoscopic stomach / duodenal erosion 12 weeks
Secondary The incidence of endoscopic stomach / duodenal ulcer 12 weeks
Secondary The changes of MLS in the gastroduodenal endoscopy result compared to baseline 12 weeks
Secondary The incidence of endoscopic esophagitis 16 weeks
Secondary Rescue drug use count and the total amount 16 weeks
Secondary Changes in gastrointestinal symptoms score 16 weeks
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