The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
406
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
Kasugai-shi, Aichi-ken, Japan
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Seto-shi, Aichi-ken, Japan
Unnamed facility
Akita, Akita, Japan
Unnamed facility
Funabashi-shi, Chiba, Japan
Unnamed facility
Ichihara-shi, Chiba, Japan
Unnamed facility
Nagareyama-shi, Chiba, Japan
Unnamed facility
Matsuyama, Ehime, Japan
Unnamed facility
Niihama-shi, Ehime, Japan
Unnamed facility
Saijo-shi, Ehime, Japan
...and 87 more locations