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

NCT ID: NCT01398410

Last Updated: 2015-12-21

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

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-02-28

Brief Summary

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The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or 10 mg tablets administered once daily in participants who were confirmed to have no recurrence of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in the E3810-J081-308 (NCI01397448) \[Double-Blind Phase\] study. From a total of 420 participants who completed the E3810-J081-308 study, 328 entered the E3810-J081-309 (NCT01398410) study.

Detailed Description

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The E3810-J081-309 consisted of two arms: the long-term rabeprazole groups (participants from the rabeprazole 5 or 10 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study) and the newly-initiated rabeprazole groups (participants from the teprenone 150 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm of the E3810-J081-309 study).

Conditions

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Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin

Keywords

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Rabeprazole proton pump inhibitor Acetylsalicylic Acid Aspirin Gastric Ulcer Duodenal Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Rabeprazole 5 mg

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily

Rabeprazole 10 mg

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily

Interventions

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Rabeprazole

Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily

Intervention Type DRUG

Rabeprazole

Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily

Intervention Type DRUG

Other Intervention Names

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E3810, Pariet/Aciphex E3810, Pariet/Aciphex

Eligibility Criteria

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Inclusion Criteria

* Confirmed to have no recurrence of gastric or duodenal ulcer by endoscopy at the end of 24 weeks of treatment in study E3810-J081-308.
* Need to continue receiving low-dose aspirin (81 mg/day or 100 mg/day) during this study.

Exclusion Criteria

-Confirmed to have a recurrence of gastric or duodenal ulcer at the end of 24 weeks of treatment in study E3810-J081-308 (at the start of this trial) and thus are withdrawn from the trial.
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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Kitakyushu, Kitakyushu, 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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Hirakat, 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

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Countries

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Japan

Other Identifiers

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E3810-J081-309

Identifier Type: -

Identifier Source: org_study_id