A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients
1 other identifier
interventional
517
1 country
61
Brief Summary
The purpose of this study is to assess the efficacy and safety of rabeprazole 10mg once and twice daily in maintenance therapy for PPI resistant gastroesophageal reflux disease patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2013
Typical duration for phase_3
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 24, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
November 19, 2018
CompletedJune 22, 2023
February 1, 2018
2.7 years
March 24, 2014
July 12, 2017
June 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Non-recurrence at Week 52
The non-recurrence rate (at 52 weeks) was determined by the endoscopy central review panel who were blinded to the investigator's assessment, based on the modified Los Angeles Classification using endoscopy photos were submitted by each of the institutions. Participants showing Grade A or above based on the modified Los Angeles Classification were included as a recurrence.
Week 52
Secondary Outcomes (8)
Rate of Non-recurrence at Weeks 12 and 24
Weeks 12 and 24
Cumulative Non-recurrence Rate at Week 52
Week 52
Percentage of Participants With Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
From Week 4 up to Week 52
Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
From Week 4 up to Week 52
Severity of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period
From Week 4 up to Week 52
- +3 more secondary outcomes
Study Arms (4)
Arm A
EXPERIMENTALArm B
EXPERIMENTALArm C
EXPERIMENTALArm D
EXPERIMENTALInterventions
Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
Eligibility Criteria
You may qualify if:
- Subjects fulfilling all of the below criteria shall be eligible for the study:
- Patients diagnosed with gastroesophageal reflux disease who are shown through endoscopic examination to have mucosal lesions (erosions, ulcers)
- Patients shown through endoscopy not to have recovered despite administration of PPI once daily for eight weeks.
- Patients over 20 years of age who have freely given their informed consent in writing to participation in the study.
- Patients who, having received a full explanation of the matters that must be adhered to during the study, intend to adhere to their requirements, and are capable of doing so.
You may not qualify if:
- Subjects fulfilling any of the following criteria shall be excluded from the study:
- Patients considered candidates for surgical treatment of the upper gastrointestinal tract due to perforation, esophageal stricture, pyloric stenosis, esophageal varices, etc.
- Patients with Zollinger-Ellison syndrome.
- Patients with gastrointestinal hemorrhage.
- Patients with serious cardiovascular disease, cerebrovascular disease, hematological disorders, renal disease, liver disease, malignant tumors, etc.
- Patients with long segment Barrett's esophagus.
- Patients with open gastric or duodenal ulcers.
- Patients with drug allergies or a past history of drug allergies to PPI.
- Patients who are taking other drugs under development, or have done so within 12 weeks prior to enrollment.
- Patients who are, or may be pregnant, patients who wish to become pregnant during the study period, patients who are breastfeeding, and patients or their partners who do not wish to use reliable contraceptive measures.
- Patients with a history of dependence on or abuse of drugs or alcohol within the past two years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (61)
Unknown Facility
Nagoya, Aichi-ken, Japan
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Inzai, Chiba, Japan
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Kamagaya, Chiba, Japan
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Matsuyama, Ehime, Japan
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Kitakyushu, Fukuoka, Japan
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Koga, Fukuoka, Japan
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Kōriyama, Fukushima, Japan
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Annaka, Gunma, Japan
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Fukuyama, Hiroshima, Japan
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Asahikawa, Hokkaido, Japan
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Ishikari, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Amagasaki, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Nishinomiya, Hyōgo, Japan
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Furukawa, Ibaraki, Japan
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Tsuchiura, Ibaraki, Japan
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Takamatsu, Kagawa-ken, Japan
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Ichikikushikino-shi, Kagoshima-ken, Japan
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Kamakura, Kanagawa, Japan
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Kawasaki, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Sendai, Miyagi, Japan
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Suwa, Nagano, Japan
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Beppu, Oita Prefecture, Japan
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Fujiidera, Osaka, Japan
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Hirakata, Osaka, Japan
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Kishiwada, Osaka, Japan
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Takatsuki, Osaka, Japan
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Karatsu, Saga-ken, Japan
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Ureshino, Saga-ken, Japan
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Ageo, Saitama, Japan
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Hiki, Saitama, Japan
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Toda, Saitama, Japan
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Wako, Saitama, Japan
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Izumo, Shimane, Japan
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Fujieda, Shizuoka, Japan
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Hamamatsu, Shizuoka, Japan
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Ōtawara, Tochigi, Japan
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Adachi City, Tokyo, Japan
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Bunkyo, Tokyo, Japan
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Chūō, Tokyo, Japan
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Koto, Tokyo, Japan
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Minato, Tokyo, Japan
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Nerima City, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Setagaya City, Tokyo, Japan
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Shibuya City, Tokyo, Japan
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Shinagawa, Tokyo, Japan
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Toshima City, Tokyo, Japan
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Akita, Japan
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Fukuoka, Japan
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Hiroshima, Japan
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Kochi, Japan
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Kyoto, Japan
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Nagasaki, Japan
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Osaka, Japan
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Ōita, Japan
Unknown Facility
Saga, Japan
Unknown Facility
Saitama, Japan
Unknown Facility
Yamagata, Japan
Related Publications (1)
Kinoshita Y, Kato M, Fujishiro M, Masuyama H, Nakata R, Abe H, Kumagai S, Fukushima Y, Okubo Y, Hojo S, Kusano M. Efficacy and safety of twice-daily rabeprazole maintenance therapy for patients with reflux esophagitis refractory to standard once-daily proton pump inhibitor: the Japan-based EXTEND study. J Gastroenterol. 2018 Jul;53(7):834-844. doi: 10.1007/s00535-017-1417-z. Epub 2017 Nov 29.
PMID: 29188387DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Public Relations Group (EA Pharma Co., Ltd.)
- Organization
- Eisai Co., Ltd. and EA Pharma Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2014
First Posted
May 9, 2014
Study Start
September 1, 2013
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
June 22, 2023
Results First Posted
November 19, 2018
Record last verified: 2018-02