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

Eisai

Status and phase: Completed; Phase 3; Phase 2

Conditions: Gastric or Duodenal Ulcers Caused by Low-dose Aspirin

Treatments: Drug: Teprenone; Drug: E3810

Study type: Interventional

Funder types: Industry

Identifiers

NCT01397448

E3810-J081-308

Details and patient eligibility

About

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.

Enrollment: 472 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

472 participants in 3 patient groups

E3810 5 mg

Experimental group

Treatment:

Drug: E3810

Drug: E3810

E3810 10 mg

Experimental group

Treatment:

Drug: E3810

Drug: E3810

Teprenone 150 mg

Active Comparator group

Treatment:

Drug: Teprenone