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

Eisai Co., Ltd.472 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

472

Conditions

Gastric or Duodenal Ulcers Caused by Low-dose Aspirin

Interventions

E3810DRUG

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.

E3810DRUG

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.

TeprenoneDRUG

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

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (49)

Outcomes

Primary Outcomes

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.

Time frame: 24 weeks

Secondary Outcomes

Cumulative Incidence of Bleeding Ulcers

Time frame: 24 weeks

Data from ClinicalTrials.gov

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Unnamed 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

...and 39 more locations