Refractory Reflux EsophagitisPhase 2/3NCT00770913
Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis
A Phase 2/3 study testing E3810 in people with Refractory Reflux Esophagitis, run by Eisai Co., Ltd. at 54 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Refractory Reflux Esophagitis
- What is being tested?
- E3810
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 54 sitesJapan
- Study dates
- Oct 2008to Mar 2010
- 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
- Patients who have mucosal breaks (erosions, ulcers) on endoscopy and are diagnosed with reflux esophagitis.
- Proton Pump Inhibitor standard dose-resistant reflux esophagitis.
- Patients who are 20 years and older when informed consent is obtained.
Who cannot join
- Patients with a concurrent severe illness, serious heart disease, comorbid severe disease such as hematology, kidney disease, or liver disease.
- Patients with malignancy.
- Patients who are taking another trial drug or the interval between the end of treatment and screening is less than 12 weeks.
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
Japan54 sites
Study site
Abiko, Chiba
Study site
Akita, Akita
Study site
Asahikawa, Hokkaido
Study site
Beppu, Oita Prefecture
Study site
Bunkyo, Tokyo
Study site
Chikushino-shi, Fukuoka
Study site
Fujieda, Shizuoka
Study site
Fukuoka, Fukuoka
Study site
Gifu, Gifu
Study site
Hamamatsu, Shizuoka
Study site
Hashima, Gifu
Study site
Hirakata, Osaka
Study site
Hiroshima, Hiroshima
Study site
Hitachi, Ibaraki
Study site
Hōfu, Yamaguchi
Study site
Ishinomaki, Miyagi
Study site
Itami, Hyōgo
Study site
Izumo, Shimane
Study site
Kagoshima, Kagoshima-ken
Study site
Karatsu, Saga-ken
Study site
Kashiwa, Chiba
Study site
Kawasaki, Kanagawa
Study site
Kirishima, Kagoshima-ken
Study site
Kochi, Kochi
Study site
Kōriyama, Fukushima
Study site
Kumamoto, Kumamoto
Study site
Kusatsu, Shiga
Study site
Kyoto, Kyoto
Study site
Maebashi, Gunma
Study site
Matsue, Shimane
Study site
Nagakute, Aichi-ken
Study site
Nagasaki, Nagasaki
Study site
Nagoya, Aichi-ken
Study site
Nishinomiya, Hyōgo
Study site
Ohtawara, Tochigi
Study site
Ōita, Oita Prefecture
Study site
Okayama, Okayama-ken
Study site
Omuta, Fukuoka
Study site
Osaka, Osaka
Study site
Saga, Saga-ken
Study site
Sapporo, Hokkaido
Study site
Setagaya City, Tokyo
Study site
Shimada, Shizuoka
Study site
Shimonoseki, Yamaguchi
Study site
Shinagawa, Tokyo
Study site
Shinjuku, Tokyo
Study site
Shizuoka, Shizuoka
Study site
tabashi City, Tokyo
Study site
Tagawa, Fukuoka
Study site
Takamatsu, Kagawa-ken
Study site
Yachiyo, Chiba
Study site
Yamagata, Yamagata
Study site
Yamatokōriyama, Nara
Study site
Yokohama, Kanagawa
About this study
The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.
Read the detailed description
This is a multicenter, randomized, double-blinded study. The efficacy with E3810 20 mg once daily is compared with E3810 20 mg twice daily and 10 mg twice daily using endoscopic recovery. The frequency of adverse event, etc., will be compared among 3 groups for safety assessment.
- Conditions
- Refractory Reflux Esophagitis
- Being tested
- E3810
- Keywords
- reflux esophagitis, rabeprazole, GERD, Japan
- Medical subject headings
- Esophagitis, Peptic, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E3810Drug
Also called Aciphex
20 mg taken orally, once a day for 8 weeks.
E3810Drug
Also called Aciphex
10 mg, taken orally, twice a day for 8 weeks.
E3810Drug
Also called Aciphex
20 mg taken orally, twice a day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: E3810 |
| 2 | Experimental | Not described Receives: Drug: E3810 |
| 3 | Experimental | Not described Receives: Drug: E3810 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)
Grade N indicates a normal appearance of lower esophageal mucosa
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 posted10 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2009
- Study completionMar 2010
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 Refractory Reflux EsophagitisStudies 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
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomoki Kubota, Study director, New Product Development Dept., Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770913
- Sponsor's protocol ID
- E3810-J081-304
- Status last verified
- Jun 2010
- First submitted
- 9 Oct 2008
- Last updated
- 18 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis
- ClinicalTrials.gov ID
- NCT00770913
- Acronym / sponsor ID
- E3810-J081-304
- Conditions
- Refractory Reflux Esophagitis
- Keywords
- reflux esophagitis, rabeprazole, GERD, Japan
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 Oct 2008 (estimated)
- Results
- Posted 13 Apr 2012
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 evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.
Detailed description
This is a multicenter, randomized, double-blinded study. The efficacy with E3810 20 mg once daily is compared with E3810 20 mg twice daily and 10 mg twice daily using endoscopic recovery. The frequency of adverse event, etc., will be compared among 3 groups for safety assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: E3810 |
| 2 | Experimental | Drug: E3810 |
| 3 | Experimental | Drug: E3810 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have mucosal breaks (erosions, ulcers) on endoscopy and are diagnosed with reflux esophagitis.
- Proton Pump Inhibitor standard dose-resistant reflux esophagitis.
- Patients who are 20 years and older when informed consent is obtained.
Key exclusion criteria (3 listed)
- Patients with a concurrent severe illness, serious heart disease, comorbid severe disease such as hematology, kidney disease, or liver disease.
- Patients with malignancy.
- Patients who are taking another trial drug or the interval between the end of treatment and screening is less than 12 weeks.
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 |
|---|---|---|
| E3810Also: Aciphex20 mg taken orally, once a day for 8 weeks. | Drug | 1 |
| E3810Also: Aciphex10 mg, taken orally, twice a day for 8 weeks. | Drug | 2 |
| E3810Also: Aciphex20 mg taken orally, twice a day for 8 weeks. | Drug | 3 |
Primary outcome
Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N)
Time frame: 8 weeks
Grade N indicates a normal appearance of lower esophageal mucosa
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2012.
- 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.
Tomoki Kubota study director
New Product Development Dept., Clinical Research Center
54 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 E3810 in people with Refractory Reflux Esophagitis, run by Eisai Co., Ltd. at 54 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 18 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 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 13 Apr 2012). 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 Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) (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 18 Apr 2012.