Status:
COMPLETED
Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
The E3810-J081-309 consisted of two arms: the long-term rabeprazole groups (participants from the rabeprazole 5 or 10 mg arm of the E3810-J081-308 study who entered the rabeprazole 5 mg or 10 mg arm o...
Eligibility Criteria
Inclusion
- 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or duodenal ulcer at the end of 24 weeks of treatment in study E3810-J081-308 (at the start of this trial) and thus are withdrawn from the trial.
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT01398410
Start Date
December 1 2011
End Date
February 1 2014
Last Update
December 21 2015
Active Locations (50)
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1
Kasugai, Aichi-ken, Japan
2
Nagoya, Aichi-ken, Japan
3
Ichikawa, Chiba, Japan
4
Chikushino-shi, Fukuoka, Japan