Cardio-cerebrovascular DiseasePhase 3CARENCT01051388
Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation
A Phase 3 study testing Low-dose PPI (Rabeprazole sodium), High-dose PPI (Rabeprazole sodium) and Non-PPI (Gefarnate) in people with Cardio-cerebrovascular Disease, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
The aim of this study is to evaluate the efficacy of proton pump inhibitor (PPI), comparing to the mucosal defensive drug, in the prevention of the recurrence of gastric and/or duodenal ulcers during 12 weeks observation in patients receiving low-dose aspirin for vascular protection. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cardio-cerebrovascular Disease
- What is being tested?
- Low-dose PPI (Rabeprazole sodium), High-dose PPI (Rabeprazole sodium) and Non-PPI (Gefarnate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2008to Dec 2010
- Phase
- Phase 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with ischemic heart failure or vascular disease of brain
- patients taking low-dose aspirin to prevent relapse of vascular diseases
- patients who experienced gastric and/or duodenal ulcers before the study by the endoscopy
- patients without active gastric and duodenal ulcers
- more than 20 years old
- outpatients
- patients written an informed consent
Who cannot join
- patients with ischemic heart failure, which are acute phase, unstable condition or under 6 months after stent-instillation
- patients with brain vascular disease , which are acute phase, unstable condition or under 3 months after the first attack
- patients who are uncontrolled and complicated disease, for example thrombocytopenia, and unsuitable for this study as judged by investigator
- patients who are treated with steroid hormones
- patients who are women of, pregnant and lactating and childbearing
- patients who are alcoholism
Show all 9Show fewer
- patients who show the hypersensitivity for test drugs
- patients who are enrolled in another clinical study
- patients who are judged as unsuitable by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prophylactic Efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients Continuously Treated With Low-dose Aspirin-Randomized, Multi-center, Single-blinded, Parallel-group, Comparative Study
The aim of this study is to evaluate the efficacy of proton pump inhibitor (PPI), comparing to the mucosal defensive drug, in the prevention of the recurrence of gastric and/or duodenal ulcers during 12 weeks observation in patients receiving low-dose aspirin for vascular protection.
Read the detailed description
The events of recurrence of gastric and/or duodenal ulcers will be evaluated due to a blinded manner by specialized endoscopists at pre- and post administration during 12 weeks administration of PPI (Rabeprazole sodium 10 mg or 20 mg tablet once a day) or the mucosal defensive drug (Gefarnate 50mg Capsule twice a day).
- Conditions
- Cardio-cerebrovascular Disease
- Being tested
- Low-dose PPI (Rabeprazole sodium), High-dose PPI (Rabeprazole sodium), Non-PPI (Gefarnate)
- Keywords
- The efficacy of PPI, Patients receiving low-dose aspirin for vascular protection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose PPI (Rabeprazole sodium)Drug
PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three
High-dose PPI (Rabeprazole sodium)Drug
PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three)
Non-PPI (Gefarnate)Drug
The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three)
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Low-dose PPI (Rabeprazole sodium 10 mg) Receives: Drug: Low-dose PPI (Rabeprazole sodium) |
| Group II | Active comparator | High-dose PPI (Rabeprazole sodium 20 mg) Receives: Drug: High-dose PPI (Rabeprazole sodium) |
| Group III | Active comparator | Non-PPI (Gefarnate) Receives: Drug: Non-PPI (Gefarnate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic Recurrence of Gastric and/or Duodenal Ulcers
Measured: 12 weeks after giving medication
Secondary outcomes (1)
Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events
Measured: 12 weeks after giving medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startAug 2008
- Primary completionJul 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardio-cerebrovascular DiseaseStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Gastro-Intestinal Medical Care Research Center
- Investigators
- Takeshi Azuma, M.D., Ph.D., Principal investigator, Kobe University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051388
- Sponsor's protocol ID
- TRIGID0801
- Other IDs
- UMIN000002901
- Acronym
- CARE
- Status last verified
- Apr 2011
- First submitted
- 15 Jan 2010
- Last updated
- 4 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients Continuously Treated With Low-dose Aspirin-Randomized, Multi-center, Single-blinded, Parallel-group, Comparative Study
- ClinicalTrials.gov ID
- NCT01051388
- Acronym / sponsor ID
- CARE / TRIGID0801
- Conditions
- Cardio-cerebrovascular Disease
- Keywords
- The efficacy of PPI, Patients receiving low-dose aspirin for vascular protection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Gastro-Intestinal Medical Care Research Center
- Study start
- Aug 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Jan 2010 (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 aim of this study is to evaluate the efficacy of proton pump inhibitor (PPI), comparing to the mucosal defensive drug, in the prevention of the recurrence of gastric and/or duodenal ulcers during 12 weeks observation in patients receiving low-dose aspirin for vascular protection.
Detailed description
The events of recurrence of gastric and/or duodenal ulcers will be evaluated due to a blinded manner by specialized endoscopists at pre- and post administration during 12 weeks administration of PPI (Rabeprazole sodium 10 mg or 20 mg tablet once a day) or the mucosal defensive drug (Gefarnate 50mg Capsule twice a day).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Low-dose PPI (Rabeprazole sodium)Low-dose PPI (Rabeprazole sodium 10 mg) |
| Group II | Active comparator | Drug: High-dose PPI (Rabeprazole sodium)High-dose PPI (Rabeprazole sodium 20 mg) |
| Group III | Active comparator | Drug: Non-PPI (Gefarnate)Non-PPI (Gefarnate) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients with ischemic heart failure or vascular disease of brain
- patients taking low-dose aspirin to prevent relapse of vascular diseases
- patients who experienced gastric and/or duodenal ulcers before the study by the endoscopy
- patients without active gastric and duodenal ulcers
- more than 20 years old
Key exclusion criteria (9 listed)
- patients with ischemic heart failure, which are acute phase, unstable condition or under 6 months after stent-instillation
- patients with brain vascular disease , which are acute phase, unstable condition or under 3 months after the first attack
- patients who are uncontrolled and complicated disease, for example thrombocytopenia, and unsuitable for this study as judged by investigator
- patients who are treated with steroid hormones
- patients who are women of, pregnant and lactating and childbearing
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 |
|---|---|---|
| Low-dose PPI (Rabeprazole sodium)PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three | Drug | Group I |
| High-dose PPI (Rabeprazole sodium)PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three) | Drug | Group II |
| Non-PPI (Gefarnate)The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three) | Drug | Group III |
Primary outcome
Endoscopic Recurrence of Gastric and/or Duodenal Ulcers
Time frame: 12 weeks after giving medication
1 secondary outcome
Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events
Time frame: 12 weeks after giving medication
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 4 Apr 2011.
- Related InfoLink provided by the sponsor.
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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.
Takeshi Azuma, M.D., Ph.D. principal investigator
Kobe University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low-dose PPI (Rabeprazole sodium), High-dose PPI (Rabeprazole sodium) and Non-PPI (Gefarnate) in people with Cardio-cerebrovascular Disease, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
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 7 inclusion and 9 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 4 Apr 2011. 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 Japan. 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. 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 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?
Endoscopic Recurrence of Gastric and/or Duodenal Ulcers (time frame: 12 weeks after giving medication). 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 4 Apr 2011.