Peptic UlcerPhase 2NCT02342470
Efficacy and Safety of PMK-S005 in the Prevention of Recurrent Peptic Ulcer in Low-dose Aspirin Users
A Phase 2 study testing PMK-S005 1, PMK-S005 2 and PMK-S005 3 in people with Peptic Ulcer, run by PharmaKing at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peptic Ulcer
- What is being tested?
- PMK-S005 1, PMK-S005 2 and PMK-S005 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Nov 2014to 8 Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bundang Seoul University Hospital
Kumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, 463-707
About this study
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
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.
- Conditions
- Peptic Ulcer
- Being tested
- Placebo, PMK-S005 1, PMK-S005 2, PMK-S005 3
- Keywords
- prevention, Recurrent peptic ulcer
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Drug : Placebo
PMK-S005 1Drug
Drug : PMK-S005 1 (50mg)
PMK-S005 2Drug
Drug : PMK-S005 2 (100mg)
PMK-S005 3Drug
Drug : PMK-S005 3 (150mg)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Comparator / Bid Receives: Drug: Placebo |
| PMK-S005 1 | Experimental | Total 50mg, by mouth, bid Receives: Drug: PMK-S005 1 |
| PMK-S005 2 | Experimental | Total 100mg, by mouth, bid Receives: Drug: PMK-S005 2 |
| PMK-S005 3 | Experimental | Total 150mg, by mouth, bid Receives: Drug: PMK-S005 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of endoscopic peptic ulcer
Measured: 12 weeks
Secondary outcomes (7)
The incidence of endoscopic stomach / duodenal mucosal disease(erosion, ulcer)
Measured: 12 weeks
The incidence of endoscopic stomach / duodenal erosion
Measured: 12 weeks
The incidence of endoscopic stomach / duodenal ulcer
Measured: 12 weeks
The changes of MLS in the gastroduodenal endoscopy result compared to baseline
Measured: 12 weeks
The incidence of endoscopic esophagitis
Measured: 16 weeks
Rescue drug use count and the total amount
Measured: 16 weeks
Changes in gastrointestinal symptoms score
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study start24 Nov 2014
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaKing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342470
- Sponsor's protocol ID
- PMK-S005_Phase II
- Status last verified
- Jan 2018
- First submitted
- 19 Dec 2014
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02342470
- Acronym / sponsor ID
- PMK-S005_Phase II
- Conditions
- Peptic Ulcer
- Keywords
- prevention, Recurrent peptic ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- PharmaKingIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2014 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Comparator / Bid |
| PMK-S005 1 | Experimental | Drug: PMK-S005 1Total 50mg, by mouth, bid |
| PMK-S005 2 | Experimental | Drug: PMK-S005 2Total 100mg, by mouth, bid |
| PMK-S005 3 | Experimental | Drug: PMK-S005 3Total 150mg, by mouth, bid |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboDrug : Placebo | Drug | Placebo |
| PMK-S005 1Drug : PMK-S005 1 (50mg) | Drug | PMK-S005 1 |
| PMK-S005 2Drug : PMK-S005 2 (100mg) | Drug | PMK-S005 2 |
| PMK-S005 3Drug : PMK-S005 3 (150mg) | Drug | PMK-S005 3 |
Primary outcome
The incidence of endoscopic peptic ulcer
Time frame: 12 weeks
7 secondary outcomes
The incidence of endoscopic stomach / duodenal mucosal disease(erosion, ulcer)
Time frame: 12 weeks
The incidence of endoscopic stomach / duodenal erosion
Time frame: 12 weeks
The incidence of endoscopic stomach / duodenal ulcer
Time frame: 12 weeks
The changes of MLS in the gastroduodenal endoscopy result compared to baseline
Time frame: 12 weeks
The incidence of endoscopic esophagitis
Time frame: 16 weeks
Rescue drug use count and the total amount
Time frame: 16 weeks
Changes in gastrointestinal symptoms score
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PMK-S005 1, PMK-S005 2 and PMK-S005 3 in people with Peptic Ulcer, run by PharmaKing at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of endoscopic peptic ulcer (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.