Stomach UlcerPhase 4NCT00125736
A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium
A Phase 4 study testing E0671 and rabeprazole sodium in people with Stomach Ulcer, run by Eisai Co., Ltd. at 43 sites in Japan.
Trial summary
The purpose of this study is to investigate the efficacy and safety of combination use of E0671 and Rabeprazole Sodium in patients with gastric ulcer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stomach Ulcer
- What is being tested?
- E0671 and rabeprazole sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 43 sitesJapan
- Study dates
- 1 Aug 2005to 19 Apr 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with gastric ulcer (A1-and A2-stage)
- Patients with gastric ulcer who meet all of the following items. Gender and treatment class (in-patient or out-patient) are not asked.
- Patients with endoscopically diagnosed A1- or A2-stage ulcer (by Sakita/Miwa classification).
- Patients who are not younger than 20 years of age at the time of obtaining informed consent.
- Patients who meet any of the following conditions:
- H. pylori-negative
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- H. pylori-positive and not requiring eradication therapy
- H. pylori-positive and unsuccessful eradication
- Patients who are given a full explanation about the study objective and design, and able to give prior consent for study participation.
Who cannot join
- Patients with a complication of duodenal ulcer (excluding cicatrix).
- Patients with reflux esophagitis
- Patients with acute gastric mucosal lesions (AGML).
- Patients with NSAID-induced ulcer.
- Patients with linear ulcer.
- Patients with ulcer injured by endoscopy.
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- Patients who underwent gastrectomy or vagal nerve resection.
- Patients who are not applied to pharmacotherapy, i.e., perforation, pyloric stenosis, major bleeding (exposed blood vessels in the base of ulcer), etc.
- Patients receiving proton pump inhibitor (PPI) and/or teprenone preparation(s) within 1 week prior to the study administration.
- Patients with serious cardiovascular diseases (e.g., angina pectoris, heart failure, acute myocardial ischemia, severe tachyarrhythmia), serious hematological disorders (e.g., aplastic anemia), serious renal disorders (e.g., acute, chronic renal failure), serious hepatic disorders (e.g., cirrhosis, severe hepatitis), serious pancreatic disorders (e.g., severe pancreatitis), serious psychoneuroses (e.g., schizophrenia, alcoholic dependency, drug dependency, severe depression), or cancer.
- Patients with a current or a history of drug allergy to teprenone preparation(s).
- Patients with a current or a history of drug allergy to PPI.
- Patients requiring antacid(s) containing digoxin or aluminum hydroxide/magnesium hydroxide that are suspected to exert drug interaction with rabeprazole sodium.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
Japan43 sites
Study site
Akita, Akira
Study site
Asahikawa, Hokkaido
Study site
Chikushino-shi, Fukoka
Study site
Fukoka, Fukoka
Study site
Gifu
Study site
Hamamatsu, Shizouka
Study site
Hashima, Gifu
Study site
Hasuda, Saitama
Study site
Hiroshima
Study site
Ikeda, Osaka
Study site
Izumisano, Osaka
Study site
Kadoma, Osaka
Study site
Kanazawa, Ishikawa-ken
Study site
Kariya, Aichi-ken
Study site
Kashihara, Nara
Study site
Kitaadachi-gun, Saitama
Study site
Kouchi
Study site
Kumamotoi, Kumamoto
Study site
Kurume, Fukoka
Study site
Kyoto
Study site
Matsue, Shimane
Study site
Miki, Hyōgo
Study site
Minato-ku, Tokyo
Study site
Nagoya, Aichi-ken
Study site
Nara
Study site
Nigata, Niigata
Study site
Niihama, Ehime
Study site
Ōita
Study site
Oumuta, Fukoka
Study site
Sabae, Fukui
Study site
Saga
Study site
Sapporo, Hokkaido
Study site
Sendai, Miyagi
Study site
Seto, Aichi-ken
Study site
Shimonoseki, Yamaguchi
Study site
Shinagawa-ku, Tokyo
Study site
Shinjyuku-ku, Tokyo
Study site
Tagawa, Fukoka
Study site
Takatsuki, Osaka
Study site
Toyoake, Aichi-ken
Study site
Toyohashi, Aichi-ken
Study site
Urayasu, Chiba
Study site
Yufu, Oita Prefecture
About this study
The purpose of this study is to investigate the efficacy and safety of combination use of E0671 and Rabeprazole Sodium in patients with gastric ulcer.
Read the detailed description
The efficacy and safety of E0671 in combination with Rabeprazole Sodium (i.e., 10 mg/day of rabeprazole sodium and 150 mg/day of E0671) will be investigated in patients with gastric ulcer in a multicenter, randomized, double-blind, parallel-group comparative study using a placebo control group (10 mg/day of rabeprazole sodium and placebo for E0671).
- Conditions
- Stomach Ulcer
- Being tested
- E0671, rabeprazole sodium, E0671 placebo
- Medical subject headings
- Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E0671Drug
One 50 mg capsule is orally administered three times daily (150 mg/day)
rabeprazole sodiumDrug
One 10mg tablet is administered orally each day
E0671 placeboDrug
One 50 mg capsule is orally administered three times daily (150 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| E0671 combination group | Experimental | Not described Receives: Drug: E0671; Drug: rabeprazole sodium |
| placebo combination group | Placebo comparator | Not described Receives: Drug: rabeprazole sodium; Drug: E0671 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of S2-stage transition at 8 weeks after the study administration.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study start1 Aug 2005
- Primary completion19 Apr 2007
- Study completion19 Apr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshihisa Arai, Study director, GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125736
- Sponsor's protocol ID
- E0671-J081-291
- Status last verified
- Jan 2010
- First submitted
- 29 Jul 2005
- Last updated
- 29 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium
- ClinicalTrials.gov ID
- NCT00125736
- Acronym / sponsor ID
- E0671-J081-291
- Conditions
- Stomach Ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2005 (actual)
- Primary completion
- 19 Apr 2007 (actual)
- Study completion
- 19 Apr 2007 (actual)
- First posted
- 2 Aug 2005 (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 investigate the efficacy and safety of combination use of E0671 and Rabeprazole Sodium in patients with gastric ulcer.
Detailed description
The efficacy and safety of E0671 in combination with Rabeprazole Sodium (i.e., 10 mg/day of rabeprazole sodium and 150 mg/day of E0671) will be investigated in patients with gastric ulcer in a multicenter, randomized, double-blind, parallel-group comparative study using a placebo control group (10 mg/day of rabeprazole sodium and placebo for E0671).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E0671 combination group | Experimental | Drug: E0671, Drug: rabeprazole sodium |
| placebo combination group | Placebo comparator | Drug: rabeprazole sodium, Drug: E0671 placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with gastric ulcer (A1-and A2-stage)
- Patients with gastric ulcer who meet all of the following items. Gender and treatment class (in-patient or out-patient) are not asked.
- Patients who are given a full explanation about the study objective and design, and able to give prior consent for study participation.
Key exclusion criteria (13 listed)
- Patients with a complication of duodenal ulcer (excluding cicatrix).
- Patients with reflux esophagitis
- Patients with acute gastric mucosal lesions (AGML).
- Patients with NSAID-induced ulcer.
- Patients with linear ulcer.
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 |
|---|---|---|
| E0671One 50 mg capsule is orally administered three times daily (150 mg/day) | Drug | E0671 combination group |
| rabeprazole sodiumOne 10mg tablet is administered orally each day | Drug | E0671 combination group, placebo combination group |
| E0671 placeboOne 50 mg capsule is orally administered three times daily (150 mg/day) | Drug | placebo combination group |
Primary outcome
Ratio of S2-stage transition at 8 weeks after the study administration.
Time frame: 8 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 29 Oct 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.
Toshihisa Arai study director
GI Group. Post-Marketing Clinical Research Dept., Clinical Research Center
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing E0671 and rabeprazole sodium in people with Stomach Ulcer, run by Eisai Co., Ltd. at 43 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 9 inclusion and 13 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 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 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. 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?
Ratio of S2-stage transition at 8 weeks after the study administration. (time frame: 8 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 29 Oct 2018.