Gastric Ulcers Duodenal Ulcers Caused by Low-dose AspirinPhase 2/3NCT01398410
Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
A Phase 2/3 study testing Rabeprazole in people with Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin, run by Eisai Co., Ltd. at 50 sites in Japan.
Trial summary
The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or 10 mg tablets administered once daily in participants who were confirmed to have no recurrence of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in the E3810-J081-308 (NCI01397448)… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin
- What is being tested?
- Rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 50 sitesJapan
- Study dates
- Dec 2011to Feb 2014
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Confirmed to have no recurrence of gastric or duodenal ulcer by endoscopy at the end of 24 weeks of treatment in study E3810-J081-308.
- Need to continue receiving low-dose aspirin (81 mg/day or 100 mg/day) during this study.
Who cannot join
- -Confirmed to have a recurrence of gastric or duodenal ulcer at the end of 24 weeks of treatment in study E3810-J081-308 (at the start of this trial) and thus are withdrawn from the trial.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
Japan50 sites
Study site
Asahikawa, Hokkaido
Study site
Beppu, Oita Prefecture
Study site
Chikuma, Nagano
Study site
Chikushino-shi, Fukuoka
Study site
Daitō, Osaka
Study site
Ebino, Miyazaki
Study site
Fujisawa, Kanagawa
Study site
Fukuoka, Fukuoka
Study site
Gifu, Gifu
Study site
Hamamatsu, Shizuoka
Study site
Hirakat, Osaka
Study site
Hitachi, Ibaraki
Study site
Hitoyoshi, Kumamoto
Study site
Ichikawa, Chiba
Study site
Itami, Hyōgo
Study site
Izumo, Shimane
Study site
Karatsu, Saga-ken
Study site
Kasugai, Aichi-ken
Study site
Kawasaki, Kanagawa
Study site
Kitakyushu, Fukuoka
Study site
Kitakyushu, Kitakyushu
Study site
Kobe, Hyōgo
Study site
Kochi, Kochi
Study site
Koga, Fukuoka
Study site
Kumamoto, Kumamoto
Study site
Kyoto, Kyoto
Study site
Maebashi, Gunma
Study site
Matsubara, Osaka
Study site
Matsumoto, Nagano
Study site
Mitaka, Tokyo
Study site
Miyazaki, Miyazaki
Study site
Nagano, Nagano
Study site
Nagasaki, Nagasaki
Study site
Nagoya, Aichi-ken
Study site
Ohtawara, Tochigi
Study site
Ōita, Oita Prefecture
Study site
Osaka, Osaka
Study site
Saga, Saga-ken
Study site
Sagamihara, Kanagawa
Study site
Sapporo, Hokkaido
Study site
Setagaya City, Tokyo
Study site
Shinjuku, Tokyo
Study site
Shizuoka, Shizuoka
Study site
Suzaka, Nagano
Study site
Takatsuki, Osaka
Study site
Tomakomai, Hokkaido
Study site
Ureshino, Saga-ken
Study site
Yao, Osaka
Study site
Yokohama, Kanagawa
Study site
Yufu, Oita Prefecture
About this study
Official title: Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment. - A Multicenter, Randomized, Parallel-group, Open-label Trial-
The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or 10 mg tablets administered once daily in participants who were confirmed to have no recurrence of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in the E3810-J081-308 (NCI01397448) [Double-Blind Phase] study. From a total of 420 participants who completed the E3810-J081-308 study, 328 entered the E3810-J081-309 (NCT01398410) study.
Read the detailed description
The E3810-J081-309 consisted of two arms: the long-term rabeprazole groups (participants from the rabeprazole 5 or 10 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study) and the newly-initiated rabeprazole groups (participants from the teprenone 150 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study).
- Being tested
- Rabeprazole
- Keywords
- Rabeprazole, proton pump inhibitor, Acetylsalicylic Acid, Aspirin, Gastric Ulcer, Duodenal Ulcer
- Medical subject headings
- Stomach Ulcer, Duodenal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RabeprazoleDrug
Also called E3810, Pariet/Aciphex
Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
RabeprazoleDrug
Also called E3810, Pariet/Aciphex
Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
| Study group | Role | What they receive |
|---|---|---|
| Rabeprazole 5 mg | Experimental | Not described Receives: Drug: Rabeprazole |
| Rabeprazole 10 mg | Experimental | Not described Receives: Drug: Rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment Emergent Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The data is presented as percentage of participants with treatment emergent AEs.
Measured: For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase)
Secondary outcomes (1)
Cumulative Recurrent Rate of Gastric or Duodenal Ulcers
Mucosal injuries with a white coat measuring greater than or equal to 3 mm in diameter was diagnosed as ulcers. When ulcer was confirmed by endoscopic examination during the trial, it was regarded as recurrence of ulcer and the trial was discontinued for the participant involved. The presence or absence of ulcer recurrence was determined by the endoscopy central review panel that were blinded to the investigators' assessments. Cumulative recurrent rate was estimated by the Kaplan-Meier method. The data is presented as percentage of participants with cumulative recurrent rate of gastric or duodenal ulcers.
Measured: Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastric Ulcers Duodenal Ulcers Caused by Low-dose AspirinStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nobuyuki Sugisaki, Study director, Japan/Asia Clinical Research Product Creation Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398410
- Sponsor's protocol ID
- E3810-J081-309
- Status last verified
- Nov 2015
- First submitted
- 18 Jul 2011
- Last updated
- 21 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment. - A Multicenter, Randomized, Parallel-group, Open-label Trial-
- ClinicalTrials.gov ID
- NCT01398410
- Acronym / sponsor ID
- E3810-J081-309
- Keywords
- Rabeprazole, proton pump inhibitor, Acetylsalicylic Acid, Aspirin, Gastric Ulcer, Duodenal Ulcer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Posted 16 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or 10 mg tablets administered once daily in participants who were confirmed to have no recurrence of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in the E3810-J081-308 (NCI01397448) [Double-Blind Phase] study. From a total of 420 participants who completed the E3810-J081-308 study, 328 entered the E3810-J081-309 (NCT01398410) study.
Detailed description
The E3810-J081-309 consisted of two arms: the long-term rabeprazole groups (participants from the rabeprazole 5 or 10 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study) and the newly-initiated rabeprazole groups (participants from the teprenone 150 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rabeprazole 5 mg | Experimental | Drug: Rabeprazole |
| Rabeprazole 10 mg | Experimental | Drug: Rabeprazole |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed to have no recurrence of gastric or duodenal ulcer by endoscopy at the end of 24 weeks of treatment in study E3810-J081-308.
- Need to continue receiving low-dose aspirin (81 mg/day or 100 mg/day) during this study.
Key exclusion criteria (1 listed)
- -Confirmed to have a recurrence of gastric or duodenal ulcer at the end of 24 weeks of treatment in study E3810-J081-308 (at the start of this trial) and thus are withdrawn from the trial.
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 |
|---|---|---|
| RabeprazoleAlso: E3810, Pariet/AciphexParticipants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily | Drug | Rabeprazole 5 mg |
| RabeprazoleAlso: E3810, Pariet/AciphexParticipants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily | Drug | Rabeprazole 10 mg |
Primary outcome
Percentage of Participants With Treatment Emergent Adverse Events (AEs)
Time frame: For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase)
An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The data is presented as percentage of participants with treatment emergent AEs.
1 secondary outcome
Cumulative Recurrent Rate of Gastric or Duodenal Ulcers
Time frame: Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Nobuyuki Sugisaki study director
Japan/Asia Clinical Research Product Creation Unit
50 sites 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 Rabeprazole in people with Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin, run by Eisai Co., Ltd. at 50 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 2 inclusion and 1 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 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 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.
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?
Yes. Results are posted in the registry (first posted 16 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Treatment Emergent Adverse Events (AEs) (time frame: For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase)). 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 21 Dec 2015.