ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02342470
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
PharmaKing

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.

Condition or disease Intervention/treatment Phase
Peptic Ulcer Drug: Placebo Drug: PMK-S005 1 Drug: PMK-S005 2 Drug: PMK-S005 3 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 24, 2014
Actual Primary Completion Date : December 8, 2017
Actual Study Completion Date : December 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer
Drug Information available for: Aspirin

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)




Primary Outcome Measures :
  1. The incidence of endoscopic peptic ulcer [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The incidence of endoscopic stomach / duodenal mucosal disease(erosion, ulcer) [ Time Frame: 12 weeks ]
  2. The incidence of endoscopic stomach / duodenal erosion [ Time Frame: 12 weeks ]
  3. The incidence of endoscopic stomach / duodenal ulcer [ Time Frame: 12 weeks ]
  4. The changes of MLS in the gastroduodenal endoscopy result compared to baseline [ Time Frame: 12 weeks ]
  5. The incidence of endoscopic esophagitis [ Time Frame: 16 weeks ]
  6. Rescue drug use count and the total amount [ Time Frame: 16 weeks ]
  7. Changes in gastrointestinal symptoms score [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342470


Locations
Korea, Republic of
Bundang Seoul University Hospital
Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
PharmaKing

Responsible Party: PharmaKing
ClinicalTrials.gov Identifier: NCT02342470     History of Changes
Other Study ID Numbers: PMK-S005_Phase II
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by PharmaKing:
prevention
Recurrent peptic ulcer

Additional relevant MeSH terms:
Aspirin
Ulcer
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics