The purpose of this study is to confirm the efficacy of TAK-438, once daily (QD), compared to lansoprazole for the maintenance treatment of healed erosive esophagitis and to determine the clinical dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
607
In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 10 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks. In the maintenance treatment period, the participants will receive treatment of TAK-438 placebo-matching tablets, orally, once daily and lansoprazole 15 mg, capsules, orally, once daily for up to 24 weeks.
Unnamed facility
Kashiwa-shi, Chiba, Japan
Endoscopically confirmed recurrence rate of erosive esophagitis after 24 weeks of maintenance treatment
Endoscopic recurrence of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade A to D as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break \<5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and \<75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).
Time frame: 24 Weeks.
Endoscopically confirmed recurrence rate of erosive esophagitis after 12 weeks of maintenance treatment
Time frame: 12 Weeks.
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Unnamed facility
Yachiyo-shi, Chiba, Japan
Unnamed facility
Saijo-shi, Ehime, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Kasuya-gun, Fukuoka, Japan
Unnamed facility
Koriyama-shi, Fukushima, Japan
Unnamed facility
Takayama-shi, Gifu, Japan
Unnamed facility
Annaka-shi, Gunma, Japan
Unnamed facility
Asahikawa-shi, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
...and 27 more locations