The purpose of this study is to determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
305
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Abiko-shi, Chiba, Japan
Incidence of Treatment-emergent Adverse Events
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit.
Time frame: 52 Weeks
Change from Baseline in Laboratory Values
Time frame: Baseline and Week 52
Change from Baseline in Electrocardiograms
Time frame: Baseline and Week 52
Change from Baseline in Vital Signs
Time frame: Baseline and Week 52
Change from Baseline in Serum Gastrin
Time frame: Baseline and Week 52
Change from Baseline in Pepsinogen I and II
Time frame: Baseline and Week 52
Endoscopically confirmed recurrence rate of Erosive Esophagitis
Time frame: 52 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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