Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
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.
Timeline
- Start
- 2011-07
- Primary completion
- 2013-03
- Completion
- 2013-06
Outcome
Met primary endpoint
registry Rabeprazole 5 mg vs Teprenone 150 mg; p <0.001; Hazard Ratio (HR) 0.11 (95% CI 0.04 to 0.31); Log Rank NCT01397448 ↗
registry Rabeprazole 10 mg vs Teprenone 150 mg; p <0.001; Hazard Ratio (HR) 0.05 (95% CI 0.01 to 0.23); Log Rank NCT01397448 ↗
release “a statistically significant reduction in the cumulative incidence of recurrent gastric or duodenal ulcer among the patient groups administered 5 mg and 10 mg” eisai.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | E3810 | Unknown | 5 mg | Oral |
| Subject | E3810 | Unknown | 10 mg | Oral |
| Comparator | Teprenone | Unknown | 50 mg | Oral |