Gastric UlcerNCT02423187
Rabeprazole Specific Clinical Experience Investigation for the Long-term Combination Therapy With Low-dose Aspirin
An observational study of Gastric Ulcer and Duodenal Ulcer, run by Eisai Co., Ltd. at 3 sites in Japan.
Trial summary
To investigate the safety and efficacy of long-term combination therapy with rabeprazole and low-dose aspirin. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Ulcer, Duodenal Ulcer
- How many people
- 1,568 participants
- Where
- 3 sitesJapan
- Study dates
- 17 Mar 2015to 30 Oct 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with long-term combination therapy with low-dose aspirin
Who may be able to join
- Patients taking long-term low-dose aspirin for prevention of thrombus/embolism at the start of administration of rabeprazole (including patients who start low-dose aspirin on the same day as the start of administration of rabeprazole).
- Patients with a history of gastric/duodenal ulcers.
- Patients requiring long-term use of rabeprazole for prevention of recurrence of gastric/duodenal ulcers induced by low-dose aspirin.
Who cannot join
- Patients with gastric/duodenal ulcers at the start of administration of rabeprazole.
- Patients with active upper gastrointestinal bleeding at the start of administration of rabeprazole.
- Patients with contraindication for rabeprazole.
Trial locations and contacts
3 sites in 1 country.
About this study
To investigate the safety and efficacy of long-term combination therapy with rabeprazole and low-dose aspirin.
- Conditions
- Gastric Ulcer, Duodenal Ulcer
- Being tested
- No Intervention
- Keywords
- Stomach ulcer, Duodenal ulcer, Rabeprazole, Recurrence
- Medical subject headings
- Stomach Ulcer, Duodenal Ulcer, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Participants with combination therapy (rabeprazole and low-dose aspirin) Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse drug reactions
Measured: 52 weeks
Secondary outcomes (1)
Recurrence rate of peptic ulcer
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study start17 Mar 2015
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,568 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katsuya Sugizaki, Study director, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423187
- Sponsor's protocol ID
- PRT12T
- Status last verified
- Jul 2018
- First submitted
- 17 Apr 2015
- Last updated
- 28 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rabeprazole Specific Clinical Experience Investigation for the Long-term Combination Therapy With Low-dose Aspirin
- ClinicalTrials.gov ID
- NCT02423187
- Acronym / sponsor ID
- PRT12T
- Conditions
- Gastric Ulcer, Duodenal Ulcer
- Keywords
- Stomach ulcer, Duodenal ulcer, Rabeprazole, Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,568 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2015 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 22 Apr 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.
To investigate the safety and efficacy of long-term combination therapy with rabeprazole and low-dose aspirin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Other: No InterventionParticipants with combination therapy (rabeprazole and low-dose aspirin) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with long-term combination therapy with low-dose aspirin
Key inclusion criteria (3 listed)
- Patients taking long-term low-dose aspirin for prevention of thrombus/embolism at the start of administration of rabeprazole (including patients who start low-dose aspirin on the same day as the start of administration of rabeprazole).
- Patients with a history of gastric/duodenal ulcers.
- Patients requiring long-term use of rabeprazole for prevention of recurrence of gastric/duodenal ulcers induced by low-dose aspirin.
Key exclusion criteria (3 listed)
- Patients with gastric/duodenal ulcers at the start of administration of rabeprazole.
- Patients with active upper gastrointestinal bleeding at the start of administration of rabeprazole.
- Patients with contraindication for rabeprazole.
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 |
|---|---|---|
| No Intervention | Other | Arm 1 |
Primary outcome
Incidence of adverse drug reactions
Time frame: 52 weeks
1 secondary outcome
Recurrence rate of peptic ulcer
Time frame: 52 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 28 Aug 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.
Katsuya Sugizaki study director
Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Ulcer and Duodenal Ulcer, run by Eisai Co., Ltd. at 3 sites 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 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 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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 adverse drug reactions (time frame: 52 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 28 Aug 2018.