Status:
COMPLETED
Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs
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 AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term trea...
Detailed Description
In Japan, nonsteroid anti-inflammatory drug is one of common prescribed drugs for patients as an analgesic antipyretic, treating symptoms of cold, antiphlogistic and management of pain with rheumatoid...
Eligibility Criteria
Inclusion
- The patient was on nonsteroid anti-inflammatory drug (NSAID) 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 NSAIDs.
- Past or planned surgery affecting gastric acid secretion.
- Clinically significant hepatic or renal disorder.
- Serious cardiac dysfunction, hypertension, or hematological disorder.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT00787254
Start Date
April 1 2007
End Date
May 1 2009
Last Update
February 3 2012
Active Locations (68)
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1
Kasugai-shi, Aichi-ken, Japan
2
Yotsukaido-shi, Chiba, Japan
3
Matsuyama, Ehime, Japan
4
Fukui-shi, Fukui, Japan