The purpose of this study is to confirm the efficacy of triple therapy with TAK-438, Amoxicillin and Clarithromycin, twice daily (BID) by demonstrating its non-inferiority to triple therapy with Lansoprazole, Amoxicillin and Clarithromycin in H. pylori-positive patients with scarred gastric or duodenal ulcers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
650
Unnamed facility
Abiko-shi, Chiba, Japan
H. pylori eradication rate 4 weeks after completion of first-line therapy
The participants are judged to be H. pylori-negative or H. pylori-positive based on the 13C-Urea Breath Test.
Time frame: 4-weeks post-dose (first-line therapy)
H. pylori eradication rate 4 weeks after completion of second-line therapy
Time frame: 4-weeks post-dose (second-line therapy)
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Unnamed facility
Kashiwa-shi, Chiba, Japan
Unnamed facility
Fukui-shi, Fukui, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Ishikari-shi, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Unnamed facility
Nishinomiya-shi, Hyōgo, Japan
Unnamed facility
Marugame-shi, Kagawa-ken, Japan
Unnamed facility
Takamatsu, Kagawa-ken, Japan
...and 25 more locations