Clinical trial NCT02342470: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peptic Ulcer
Keywords: prevention
Recurrent peptic ulcer
Lead sponsor: PharmaKing
Sponsor class: INDUSTRY
First posted: 2015-01-21
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The incidence of endoscopic peptic ulcer
timeFrame: 12 weeks
Secondary outcomes:
measure: The incidence of endoscopic stomach / duodenal mucosal disease(erosion, ulcer)
timeFrame: 12 weeks
measure: The incidence of endoscopic stomach / duodenal erosion
timeFrame: 12 weeks
measure: The incidence of endoscopic stomach / duodenal ulcer
timeFrame: 12 weeks
measure: The changes of MLS in the gastroduodenal endoscopy result compared to baseline
timeFrame: 12 weeks
measure: The incidence of endoscopic esophagitis
timeFrame: 16 weeks
measure: Rescue drug use count and the total amount
timeFrame: 16 weeks
measure: Changes in gastrointestinal symptoms score
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Gumi-dong
country: Korea, Republic of
facility: Bundang Seoul University Hospital
state: Bundang-gu, Seongnam-si, Gyeonggi-do
Study officials:
References: