NCT02342470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2017

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

December 19, 2014

Last Update Submit

January 20, 2018

Conditions

Peptic Ulcer

Keywords

preventionRecurrent peptic ulcer

Outcome Measures

Primary Outcomes (1)

  • The incidence of endoscopic peptic ulcer

    12 weeks

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo Comparator / Bid

Drug: Placebo

PMK-S005 1

EXPERIMENTAL

Total 50mg, by mouth, bid

Drug: PMK-S005 1

PMK-S005 2

EXPERIMENTAL

Total 100mg, by mouth, bid

Drug: PMK-S005 2

PMK-S005 3

EXPERIMENTAL

Total 150mg, by mouth, bid

Drug: PMK-S005 3

Interventions

PlaceboDRUG

Drug : Placebo

Placebo
PMK-S005 1DRUG

Drug : PMK-S005 1 (50mg)

PMK-S005 1
PMK-S005 2DRUG

Drug : PMK-S005 2 (100mg)

PMK-S005 2
PMK-S005 3DRUG

Drug : PMK-S005 3 (150mg)

PMK-S005 3

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bundang Seoul University Hospital

Kumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

January 21, 2015

Study Start

November 24, 2014

Primary Completion

December 8, 2017

Study Completion

December 8, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

KR(1)