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
1 other identifier
interventional
337
1 country
54
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2008
Shorter than P25 for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 9, 2008
CompletedFirst Posted
Study publicly available on registry
October 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
April 13, 2012
CompletedApril 18, 2012
June 1, 2010
1.1 years
October 9, 2008
September 13, 2011
April 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
8 weeks
Study Arms (3)
1
ACTIVE COMPARATOR2
EXPERIMENTAL3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (54)
Unknown Facility
Nagakute, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Akita, Akita, Japan
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Abiko, Chiba, Japan
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Kashiwa, Chiba, Japan
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Yachiyo, Chiba, Japan
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Chikushino-shi, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Omuta, Fukuoka, Japan
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Tagawa, Fukuoka, Japan
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Kōriyama, Fukushima, Japan
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Gifu, Gifu, Japan
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Hashima, Gifu, Japan
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Maebashi, Gunma, Japan
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Hiroshima, Hiroshima, Japan
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Asahikawa, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Itami, Hyōgo, Japan
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Nishinomiya, Hyōgo, Japan
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Hitachi, Ibaraki, Japan
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Takamatsu, Kagawa-ken, Japan
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Kagoshima, Kagoshima-ken, Japan
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Kirishima, Kagoshima-ken, Japan
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Kawasaki, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kochi, Kochi, Japan
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Kumamoto, Kumamoto, Japan
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Kyoto, Kyoto, Japan
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Ishinomaki, Miyagi, Japan
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Nagasaki, Nagasaki, Japan
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Yamatokōriyama, Nara, Japan
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Beppu, Oita Prefecture, Japan
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Ōita, Oita Prefecture, Japan
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Okayama, Okayama-ken, Japan
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Hirakata, Osaka, Japan
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Osaka, Osaka, Japan
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Karatsu, Saga-ken, Japan
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Saga, Saga-ken, Japan
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Kusatsu, Shiga, Japan
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Izumo, Shimane, Japan
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Matsue, Shimane, Japan
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Fujieda, Shizuoka, Japan
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Hamamatsu, Shizuoka, Japan
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Shimada, Shizuoka, Japan
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Shizuoka, Shizuoka, Japan
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Ohtawara, Tochigi, Japan
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Bunkyo, Tokyo, Japan
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Setagaya City, Tokyo, Japan
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Shinagawa, Tokyo, Japan
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Shinjuku, Tokyo, Japan
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tabashi City, Tokyo, Japan
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Yamagata, Yamagata, Japan
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Hōfu, Yamaguchi, Japan
Unknown Facility
Shimonoseki, Yamaguchi, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
In the Participant flow section, there is only one "Reason for Not Completed" per participant reported, even if there were multiple reasons.
Results Point of Contact
- Title
- Tomoki Kubota, Study Director
- Organization
- Eisai Co.,Ltd. Eisai Product Creation Systems
Study Officials
- STUDY DIRECTOR
Tomoki Kubota
New Product Development Dept., Clinical Research Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2008
First Posted
October 10, 2008
Study Start
October 1, 2008
Primary Completion
November 1, 2009
Study Completion
March 1, 2010
Last Updated
April 18, 2012
Results First Posted
April 13, 2012
Record last verified: 2010-06