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Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)

NCT ID: NCT01397448

Last Updated: 2014-11-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

472 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric or Duodenal Ulcers Caused by Low-dose Aspirin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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E3810 5 mg

Group Type EXPERIMENTAL

E3810

Intervention Type DRUG

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.

E3810 10 mg

Group Type EXPERIMENTAL

E3810

Intervention Type DRUG

E3810 10 mg Group: Orally administered E3810 5 mg placebo tablets and 10 mg tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal.

Teprenone 150 mg

Group Type ACTIVE_COMPARATOR

Teprenone

Intervention Type DRUG

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.

Interventions

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E3810

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.

Intervention Type DRUG

E3810

E3810 10 mg Group: Orally administered E3810 5 mg placebo tablets and 10 mg tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal.

Intervention Type DRUG

Teprenone

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

-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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nobuyuki Sugisaki

Role: STUDY_DIRECTOR

Japan/Asia Clinical Research Product Creation Unit

Locations

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Kasugai, Aichi-ken, Japan

Site Status

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

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Shinjuku, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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E3810-J081-308

Identifier Type: -

Identifier Source: org_study_id