The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
372
TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks.
Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.
Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.
Endoscopic Healing Rate of Duodenal Ulcer Over 6 Weeks
Endoscopic healing rate : Rate of participants who have endoscopically confirmed all of the white coatings disappeared.
Time frame: 6 weeks
Endoscopic healing Rates of Duodenal Ulcer on Endoscopy over 4 weeks
Time frame: 4 weeks
Endoscopic healing Rates of Gastric Ulcer on Endoscopy at week 2
Time frame: 2 weeks
Change from Baseline in the Incidence of Gastrointestinal Symptoms Associated with Duodenal Ulcer
Time frame: Baseline and 6 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 6 weeks.
Unnamed facility
Toyota-shi, Aichi-ken, Japan
Unnamed facility
Kamagaya-shi, Chiba, Japan
Unnamed facility
Kisarazu-shi, Chiba, Japan
Unnamed facility
Fukui-shi, Fukui, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Kitakyushu-shi, Fukuoka, Japan
Unnamed facility
Kurume-shi, Fukuoka, Japan
Unnamed facility
Onga-gun, Fukuoka, Japan
Unnamed facility
Tagawa-shi, Fukuoka, Japan
Unnamed facility
Yanagawa-shi, Fukuoka, Japan
...and 54 more locations