Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
1 other identifier
interventional
472
1 country
49
Brief Summary
The primary objective of this study to evaluate the effect of preventing recurrence of gastric or duodenal ulcers by administering E3810 5 mg or 10 mg tablets once daily or Teprenone 150 mg/day (50 mg three times daily) as a control to patients receiving low-dose aspirin and thereby examine the superiority of E3810 over Teprenone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2011
49 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
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 18, 2011
CompletedFirst Posted
Study publicly available on registry
July 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
October 23, 2014
CompletedNovember 26, 2014
October 1, 2014
1.7 years
July 18, 2011
October 20, 2014
November 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative Recurrent Rates of Gastric or Duodenal Ulcers
Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.
24 weeks
Secondary Outcomes (1)
Cumulative Incidence of Bleeding Ulcers
24 weeks
Study Arms (3)
E3810 5 mg
EXPERIMENTALE3810 10 mg
EXPERIMENTALTeprenone 150 mg
ACTIVE COMPARATORInterventions
E3810 5 mg/day Group: Orally administered E3810 5 mg tablets and E3810 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal.
Teprenone 150 mg/day Group: Orally administered E3810 5 mg placebo tablets and 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg capsules three times daily after each meal.
Eligibility Criteria
You may qualify if:
- Require long-term administration of low-dose aspirin (81 mg/day or 100 mg/day)
- Confirmed to have a history of gastric or duodenal ulcer
You may not qualify if:
- Confirmed to have acute gastro duodenal mucosal lesions, gastric or duodenal ulcer, or upper gastrointestinal (esophagus, stomach, duodenum) bleeding Confirmed to have reflux esophagitis or long segment Barrett's esophagus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (49)
Unknown Facility
Kasugai, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Ichikawa, Chiba, Japan
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Chikushino-shi, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Koga, Fukuoka, Japan
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Gifu, Gifu, Japan
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Maebashi, Gunma, Japan
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Asahikawa, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Tomakomai, Hokkaido, Japan
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Itami, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Hitachi, Ibaraki, Japan
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Fujisawa, Kanagawa, Japan
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Kawasaki, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Kochi, Kochi, Japan
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Hitoyoshi, Kumamoto, Japan
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Kumamoto, Kumamoto, Japan
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Kyoto, Kyoto, Japan
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Ebino, Miyazaki, Japan
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Miyazaki, Miyazaki, Japan
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Chikuma, Nagano, Japan
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Matsumoto, Nagano, Japan
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Nagano, Nagano, Japan
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Suzaka, Nagano, Japan
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Nagasaki, Nagasaki, Japan
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Beppu, Oita Prefecture, Japan
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Ōita, Oita Prefecture, Japan
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Yufu, Oita Prefecture, Japan
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Daitō, Osaka, Japan
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Hirakata, Osaka, Japan
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Matsubara, Osaka, Japan
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Osaka, Osaka, Japan
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Takatsuki, Osaka, Japan
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Yao, Osaka, Japan
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Karatsu, Saga-ken, Japan
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Saga, Saga-ken, Japan
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Ureshino, Saga-ken, Japan
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Izumo, Shimane, Japan
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Hamamatsu, Shizuoka, Japan
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Shizuoka, Shizuoka, Japan
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Ohtawara, Tochigi, Japan
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Mitaka, Tokyo, Japan
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Setagaya City, Tokyo, Japan
Unknown Facility
Shinjuku, Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nobuyuki Sugisaki
- Organization
- Eisai Co., Ltd.
Study Officials
- STUDY DIRECTOR
Nobuyuki Sugisaki
Japan/Asia Clinical Research Product Creation Unit
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2011
First Posted
July 19, 2011
Study Start
July 1, 2011
Primary Completion
March 1, 2013
Study Completion
June 1, 2013
Last Updated
November 26, 2014
Results First Posted
October 23, 2014
Record last verified: 2014-10