The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD), compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of non-steroidal anti-Inflammatory drug (NSAID).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
642
Recurrence rate of gastric or duodenal ulcer within 24 weeks
Mucosal defects with a white coating of 3 mm or larger will be determined as ulcers. Recurrence rate of gastric or duodenal ulcer within 24 weeks will be calculated for each treatment group.
Time frame: 24 weeks
Recurrence rate of gastric or duodenal ulcer within 12 weeks
Time frame: 12 weeks
Gastric mucosal injury
Time frame: 24 Weeks
Duodenal mucosal injury
Time frame: 24 weeks
Occurrence rate of hemorrhagic lesion in stomach or duodenum
Time frame: 24 weeks
Time to recurrence of gastric or duodenal ulcer
Time frame: 24 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 up to 24 weeks.
Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
TAK-438 placebo-matching tablets, orally, once daily for up to 24 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 92 more locations