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

NCT01398410 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 405

Last updated 2015-12-21

Study results available
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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.

Conditions

  • Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin

Interventions

DRUG

Rabeprazole

Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily

DRUG

Rabeprazole

Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Nobuyuki Sugisaki · Japan/Asia Clinical Research Product Creation Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-12-31
Completion
2014-02-28

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01398410 on ClinicalTrials.gov