Status:
TERMINATED
A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers
Lead Sponsor:
Takeda
Conditions:
Stomach Ulcer
Duodenal Ulcer
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in p...
Detailed Description
In Japan, low-dose aspirin is one of the commonly prescribed drugs for inhibiting thrombosis and thrombus formation after angina, myocardial infarction, ischemic cerebrovascular disease, coronary arte...
Eligibility Criteria
Inclusion
- The patient was on low-dose aspirin treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.
- The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.
Exclusion
- Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.
- Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.
- Current or past history of aspirin-induced asthma or hypersensitivity to nonsteroidal anti-inflammatory drugs.
- Past or planned surgery affecting gastric acid secretion.
- Clinically significant hepatic or renal disorder.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
461 Patients enrolled
Trial Details
Trial ID
NCT00762359
Start Date
May 1 2007
End Date
November 1 2008
Last Update
February 3 2012
Active Locations (65)
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1
Matsudo-shi, Chiba, Japan
2
Yotsukaido-shi, Chiba, Japan
3
Imabari, Ehime, Japan
4
Matsuyama, Ehime, Japan