Gastric Ulcer Induced by Anti-platelet AgentPhase 2/3NCT02166008
Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT
A Phase 2/3 study testing Repamipide in people with Gastric Ulcer Induced by Anti-platelet Agent and Duodenal Ulcer Induced by Anti-platelet Agent, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents Study Design: Single center, double-blind, randomized-control trial study Study drug: Repamipide vs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Ulcer Induced by Anti-platelet Agent, Duodenal Ulcer Induced by Anti-platelet Agent
- What is being tested?
- Repamipide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2014to Jun 2018
- Phase
- Phase 2/3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 year-old
- Had cardiovascular disease which needed clopidogrel and aspirin
- Stable enough for gastroscopy
Who cannot join
- Gastroscopy revealed peptic ulcer
- Had contraindication for gastroscopy
- Not allowed for gastroscopy by cardiologist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cytoprotective Agent for Peptic Ulcer Prevention in Patients Taking Dual Antiplatelet Agents: A Randomized Double-blind Placebo Control Trial Study
- Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents
- Study Design: Single center, double-blind, randomized-control trial study
- Study drug: Repamipide vs. placebo
- Assessment criteria The patients will be discharged from the study when one of the followings occurred,
- Peptic ulcer from upper endoscopy at 3 and 6 month follow up
- Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy
- Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy
- Evidence of recurrent myocardial infarction from stent thrombosis
- Conditions
- Gastric Ulcer Induced by Anti-platelet Agent, Duodenal Ulcer Induced by Anti-platelet Agent
- Being tested
- Repamipide, Placebo
- Keywords
- Repamipide, Dual antiplatelet, 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.
RepamipideDrug
PlaceboDrug
Also called Placebo will be made in the same configuration of rabamipide
| Study group | Role | What they receive |
|---|---|---|
| Repamipide | Active comparator | Rebamipide (100) 1 tab oral tid for 1 year or peptic ulcer occurred Receives: Drug: Repamipide |
| placebo | Placebo comparator | A placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient. It will be prescribed as the same regimen of Rabamipide. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of peptic ulcer by end0scopy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric Ulcer Induced by Anti-platelet AgentStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rapat Pittayanon, MD, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166008
- Sponsor's protocol ID
- RP006
- Status last verified
- Feb 2019
- First submitted
- 30 Sep 2013
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pittayanon R, Piyachaturawat P, Rerknimitr R, Prueksapanich P, Chaitongrat S, Lertsuwunseri V, Srimahachota S, Mahachai V. Cytoprotective agent for peptic ulcer prevention in patients taking dual antiplatelet agents: A randomized, double-blind placebo-controlled trial. J Gastroenterol Hepatol. 2019 Sep;34(9):1517-1522. doi: 10.1111/jgh.14671. Epub 2019 May 8.
PubMed 30919492
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytoprotective Agent for Peptic Ulcer Prevention in Patients Taking Dual Antiplatelet Agents: A Randomized Double-blind Placebo Control Trial Study
- ClinicalTrials.gov ID
- NCT02166008
- Acronym / sponsor ID
- RP006
- Conditions
- Gastric Ulcer Induced by Anti-platelet Agent, Duodenal Ulcer Induced by Anti-platelet Agent
- Keywords
- Repamipide, Dual antiplatelet, Peptic ulcer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 18 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.
- Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents
- Study Design: Single center, double-blind, randomized-control trial study
- Study drug: Repamipide vs. placebo
- Assessment criteria The patients will be discharged from the study when one of the followings occurred,
- Peptic ulcer from upper endoscopy at 3 and 6 month follow up
- Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy
- Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy
- Evidence of recurrent myocardial infarction from stent thrombosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repamipide | Active comparator | Drug: RepamipideRebamipide (100) 1 tab oral tid for 1 year or peptic ulcer occurred |
| placebo | Placebo comparator | Drug: PlaceboA placebo is a simulated or otherwise medically ineffectual treatment for a disease or other medical condition intended to deceive the recipient. It will be prescribed as the same regimen of Rabamipide. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70 year-old
- Had cardiovascular disease which needed clopidogrel and aspirin
- Stable enough for gastroscopy
Key exclusion criteria (3 listed)
- Gastroscopy revealed peptic ulcer
- Had contraindication for gastroscopy
- Not allowed for gastroscopy by cardiologist
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 |
|---|---|---|
| Repamipide | Drug | Repamipide |
| PlaceboAlso: Placebo will be made in the same configuration of rabamipide | Drug | placebo |
Primary outcome
number of peptic ulcer by end0scopy
Time frame: 1 year
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 27 Feb 2019.
- Derived from this study: PubMed 30919492Pittayanon R, Piyachaturawat P, Rerknimitr R, Prueksapanich P, Chaitongrat S, Lertsuwunseri V, Srimahachota S, Mahachai V. Cytoprotective agent for peptic ulcer prevention in patients taking dual antiplatelet agents: A randomized, double-blind placebo-controlled trial. J Gastroenterol Hepatol. 2019 Sep;34(9):1517-1522. doi: 10.1111/jgh.14671. Epub 2019 May 8.
- Institutional review board, Faculty of medicine, Chulalongkorn UniversityLink provided by the sponsor.
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 2/3 study testing Repamipide in people with Gastric Ulcer Induced by Anti-platelet Agent and Duodenal Ulcer Induced by Anti-platelet Agent, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
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 3 inclusion and 3 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 27 Feb 2019. 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 Thailand. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
number of peptic ulcer by end0scopy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02166008, which also lists 1 linked publication.
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 27 Feb 2019.