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

• Sponsor: PharmaKing (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02342470
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 4
• Actual Duration (Months): 36.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Nov 24, 2014
• Actual Primary Completion Date: Dec 8, 2017
• Actual Study Completion Date: Dec 8, 2017

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. The incidence of endoscopic peptic ulcer [12 weeks]

Secondary Outcome Measures

1. The incidence of endoscopic stomach / duodenal mucosal disease(erosion, ulcer) [12 weeks]

2. The incidence of endoscopic stomach / duodenal erosion [12 weeks]

3. The incidence of endoscopic stomach / duodenal ulcer [12 weeks]

4. The changes of MLS in the gastroduodenal endoscopy result compared to baseline [12 weeks]

5. The incidence of endoscopic esophagitis [16 weeks]

6. Rescue drug use count and the total amount [16 weeks]

7. Changes in gastrointestinal symptoms score [16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bundang Seoul University Hospital	Gumi-dong	Bundang-gu, Seongnam-si, Gyeonggi-do	Korea, Republic of	463-707

Sponsors and Collaborators

• PharmaKing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PharmaKing
• ClinicalTrials.gov Identifier: NCT02342470
• Other Study ID Numbers: PMK-S005_Phase II
• First Posted: Jan 21, 2015
• Last Update Posted: Jan 23, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by PharmaKing: prevention; Recurrent peptic ulcer
• Additional relevant MeSH terms: Peptic Ulcer; Ulcer

Study Results

No Results Posted as of Jan 23, 2018