GastritisPhase 4DAPTALBISNCT02175186
Effect of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
A Phase 4 study testing ALBIS in people with Gastritis and Gastroduodenal Ulcer, run by Young-Hak Kim, MD, PhD at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate effectiveness of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy after Percutaneous Coronary Intervention. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastritis, Gastroduodenal Ulcer
- What is being tested?
- ALBIS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jan 2015to 8 Jan 2019
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 80 years
- Patients undergoing percutaneous coronary intervention and need to take dual antiplatelet therapy continuously at least 12weeks
- Modified Lanza Score grade 0-1 measured by upper gastrointestinal endoscopy
- mild gastrointestinal symptom
- Creatinen in blood ≤ 3mg/dl
- BUN ≤ 50mg/dl
- Birilubin ≤ 3mg/dl
- AST and ALT ≤ 80U/L
Who cannot join
- Pregnant or breast feeding
- History of Stomach or esophagus surgery
- Peptic ulcer or reflux esophagitis
- Zollinger-Ellison syndrome or primary esophageal motility disorders
- Malignant tumor
- Bleeding tendency or coagulopathy
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- Contraindication of ALBIS
- Long term use of aspirin or P2Y12 receptor antagonist within 1month
- Patients who tool medicine such as PPI, APA,H2blocker, Muscarine receptor antagonist, anti-gastic agent, antacid, anticaogulant, Bisphosphonate agents, Cytotoxic drug, NSAID, adrenal cortex hormone agents (topical treatment is allowed)
- Terminal patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protective Effect of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
The purpose of this study is to evaluate effectiveness of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy after Percutaneous Coronary Intervention.
- Conditions
- Gastritis, Gastroduodenal Ulcer
- Being tested
- ALBIS, Placebo
- Keywords
- Gastritis, Gastroduodenal Ulcer, Percutaneous Coronary Revascularization, Dual Antiplatelet Therapy
- Medical subject headings
- Gastritis, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALBISDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ALBIS | Experimental | Albis Tab 2 tab twice a day 12weeks Receives: Drug: ALBIS |
| Placebo | Placebo comparator | placebo Tab 2 tab twice a day 12weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gastric ulcer
defined as a mucosal break of at least 5 mm in diameter(measured by gastrointestinal endoscopy) with depth, at 12weeks
Measured: 12weeks
Secondary outcomes (4)
Incidence of gastritis
defined as Modified Lanza Score(MLS) grade 2~4(measured by gastrointestinal endoscopy)at 12weeks
Measured: 12weeks
The Endoscopic improvement rate of hemorrhage
defined as Modified Lanza Score(MLS) grade
Measured: 12weeks
The Endoscopic improvement rate of subjective symptom
Measured: 12weeks
Total amount of antacid used during study period
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study start21 Jan 2015
- Primary completion1 Dec 2018
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Young-Hak Kim, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Young-Hak Kim, MD, PhD, Asan Medical Center
- Investigators
- Young-Hak Kim, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175186
- Sponsor's protocol ID
- AMCCV 2014-05
- Acronym
- DAPTALBIS
- Status last verified
- Mar 2023
- First submitted
- 25 Jun 2014
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02175186
- Acronym / sponsor ID
- DAPTALBIS / AMCCV 2014-05
- Conditions
- Gastritis, Gastroduodenal Ulcer
- Keywords
- Gastritis, Gastroduodenal Ulcer, Percutaneous Coronary Revascularization, Dual Antiplatelet Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Young-Hak Kim, MD, PhDUniversity, hospital or other
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 26 Jun 2014 (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 effectiveness of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy after Percutaneous Coronary Intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALBIS | Experimental | Drug: ALBISAlbis Tab 2 tab twice a day 12weeks |
| Placebo | Placebo comparator | Drug: Placeboplacebo Tab 2 tab twice a day 12weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 20 and 80 years
- Patients undergoing percutaneous coronary intervention and need to take dual antiplatelet therapy continuously at least 12weeks
- Modified Lanza Score grade 0-1 measured by upper gastrointestinal endoscopy
- mild gastrointestinal symptom
- Creatinen in blood ≤ 3mg/dl
Key exclusion criteria (10 listed)
- Pregnant or breast feeding
- History of Stomach or esophagus surgery
- Peptic ulcer or reflux esophagitis
- Zollinger-Ellison syndrome or primary esophageal motility disorders
- Malignant tumor
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 |
|---|---|---|
| ALBIS | Drug | ALBIS |
| Placebo | Drug | Placebo |
Primary outcome
Incidence of gastric ulcer
Time frame: 12weeks
defined as a mucosal break of at least 5 mm in diameter(measured by gastrointestinal endoscopy) with depth, at 12weeks
4 secondary outcomes
Incidence of gastritis
Time frame: 12weeks
The Endoscopic improvement rate of hemorrhage
Time frame: 12weeks
The Endoscopic improvement rate of subjective symptom
Time frame: 12weeks
Total amount of antacid used during study period
Time frame: 12weeks
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 22 Mar 2023.
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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.
Young-Hak Kim, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ALBIS in people with Gastritis and Gastroduodenal Ulcer, run by Young-Hak Kim, MD, PhD 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 8 inclusion and 10 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 22 Mar 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence of gastric ulcer (time frame: 12weeks). 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 22 Mar 2023.