The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant low-dose aspirin therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
439
Incidence of treatment-emergent adverse events
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit of study.
Time frame: Up to 80 weeks.
Change from baseline in Laboratory values
Time frame: Up to 80 weeks.
Change from baseline in Electrocardiograms
Time frame: Up to 80 weeks.
Change from baseline in Vital signs
Time frame: Up to 80 weeks.
Change from baseline in Serum gastrin
Time frame: Up to 80 weeks.
Change from baseline in Pepsinogen I and II
Time frame: Up to 80 weeks.
Recurrence rate of gastric or duodenal ulcer
Time frame: Up to 80 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.
TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.
Unnamed facility
Komaki-shi, Aichi-ken, Japan
Unnamed facility
Seto-shi, Aichi-ken, Japan
Unnamed facility
Akita, Akita, Japan
Unnamed facility
Ichikawa-shi, Chiba, Japan
Unnamed facility
Kisarazu-shi, Chiba, Japan
Unnamed facility
Matsudo-shi, Chiba, Japan
Unnamed facility
Imabari, Ehime, Japan
Unnamed facility
Matsuyama, Ehime, Japan
Unnamed facility
Niihama-shi, Ehime, Japan
Unnamed facility
Fukui-shi, Fukui, Japan
...and 66 more locations