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

Peptic Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342470
• Other study ID #: PMK-S005_Phase II
• 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
• 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

Related Conditions & MeSH terms

• Peptic Ulcer
• Ulcer

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