The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
409
TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Abiko-shi, Chiba, Japan
Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis
Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O 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: 8 Weeks
Endoscopic Healing Rate Over 2 Weeks of Erosive Esophagitis
Time frame: 2 Weeks
Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis
Time frame: 4 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Itoshima-shi, Fukuoka, Japan
Unnamed facility
Kurume-shi, Fukuoka, Japan
Unnamed facility
Onga-gun, Fukuoka, Japan
Unnamed facility
Gifu, Gifu, Japan
Unnamed facility
Annaka-shi, Gunma, Japan
Unnamed facility
Aki-gun, Hiroshima, Japan
Unnamed facility
Hiroshima, Hiroshima, Japan
...and 22 more locations