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

Phase 2

Completed

• Conditions: Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
• Interventions: Drug: E3810; Drug: Teprenone

• Registration Number: NCT01397448
• Lead Sponsor: Eisai Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Primary Completion: 2013-03
• Study Completion: 2013-06
• Status Verified: 2014-10
• Results First Submitted: 2014-10-20
• Results First Submitted QC: 2014-10-20
• Results First Posted: 2014-10-23
• Last Update Submitted: 2014-11-25
• Last Update Posted: 2014-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 472

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E3810 5 mg	E3810	-
E3810 10 mg	E3810	-
Teprenone 150 mg	Teprenone	-

Primary Outcome Measures

Name	Time	Method
Cumulative Recurrent Rates of Gastric or Duodenal Ulcers	24 weeks	Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.

Secondary Outcome Measures

Name	Time	Method
Cumulative Incidence of Bleeding Ulcers	24 weeks