Conditions: Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
Keywords: Rabeprazole proton pump inhibitor Acetylsalicylic Acid Aspirin Gastric Ulcer Duodenal Ulcer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 472
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: E3810 intervention 2: E3810 intervention 3: Teprenone
Intervention descriptions: intervention 1: 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 2: 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 3: 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.

Protocol document: