Long-term administration study of E3810 for the prevention of gastric or duodenal ulcer caused by low-dose aspirin

Long-term Prevention of Recurrent Gastric or Duodenal Ulcers caused by Low-dose Aspirin with Rabeprazole (E3810) Treatment. -A Multicenter, Randomized, Parallel-group, Open-label Trial-(Planetarium study)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221500

Enrollment

300

Registered

2011-06-29

Start date

2011-06-29

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric or duodenal ulcers caused by low-dose aspirin

Interventions

investigational material(s) Generic name etc : E3810(Pariet) INN of investigational material : Rabeprazole Sodium Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Confirmed to have a recurrence of gastric or duodenal ulcer at the end of 24 weeks of treatment in Trial 308 (at the start of this trial) and thus are withdrawn from the trial.

Design outcomes

Primary

Measure	Time frame
Long-term safety Adverse events (AEs), serious adverse events (SAEs), adverse drug reactions	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026