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

Study Overview
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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.

Official Title
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Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment. - A Multicenter, Randomized, Parallel-group, Double-blind Comparative Trial-

Conditions
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Gastric or Duodenal Ulcers Caused by Low-dose Aspirin

Intervention / Treatment
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* Drug: E3810
* Drug: E3810
* Drug: Teprenone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E3810 5 mg<br> | Drug: E3810<br>* 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.<br>|
| Experimental: E3810 10 mg<br> | Drug: E3810<br>* 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.<br>|
| Active Comparator: Teprenone 150 mg<br> | Drug: Teprenone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Incidence of Bleeding Ulcers |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rabeprazole, proton pump inhibitor, Acetylsalicylic Acid, Aspirin, Gastric Ulcer, Duodenal Ulcer