Phase 3 N=405 Randomized Prevention

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

Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin

Bottom Line

View on ClinicalTrials.gov: NCT01398410 ↗

Enrolled (actual)

405

Serious AEs

15.6%

Results posted

Nov 2015

Primary outcome: Primary: Percentage of Participants With Treatment Emergent Adverse Events (AEs) — 77.1; 83.8 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rabeprazole (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Eisai Co., Ltd.
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Treatment Emergent Adverse Events (AEs)	77.1; 83.8	—
SECONDARY Cumulative Recurrent Rate of Gastric or Duodenal Ulcers	0; 0; 1.3; 0; 2.8; 1.4	—

Summary

The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or 10 mg tablets administered once daily in participants who were confirmed to have no recurrence of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in the E3810-J081-308 (NCI01397448) [Double-Blind Phase] study. From a total of 420 participants who completed the E3810-J081-308 study, 328 entered the E3810-J081-309 (NCT01398410) study.

Eligibility Criteria

Inclusion Criteria

Confirmed to have no recurrence of gastric or duodenal ulcer by endoscopy at the end of 24 weeks of treatment in study E3810-J081-308.
Need to continue receiving low-dose aspirin (81 mg/day or 100 mg/day) during this study.

Exclusion Criteria

-Confirmed to have a recurrence of gastric or duodenal ulcer at the end of 24 weeks of treatment in study E3810-J081-308 (at the start of this trial) and thus are withdrawn from the trial.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01398410). 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.