Phase 3
N=471
Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
Bottom Line
View on ClinicalTrials.gov: NCT01397448 ↗Enrolled (actual)
471
Serious AEs
5.5%
Results posted
Oct 2014
Primary outcome: Primary: Cumulative Recurrent Rates of Gastric or Duodenal Ulcers — 2.8; 1.4; 21.7 Events/100 participants/24 weeks — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- E3810 (Drug); Teprenone (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eisai Co., Ltd.
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Recurrent Rates of Gastric or Duodenal Ulcers |
2.8; 1.4; 21.7 | <0.001 sig |
| SECONDARY Cumulative Incidence of Bleeding Ulcers |
0; 0; 4.6 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01397448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.