The purpose of this study is to investigate the superiority of efficacy of TAK-438, once daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
827
TAK-438 10 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.
TAK-438 20 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.
TAK-438 placebo-matching tablets, orally, once daily for 5 weeks.
Percentage of symptom-free days of heartburn symptoms
Heartburn symptoms will be collected by participant diaries.
Time frame: Week 4
Cumulative symptom improvement rate of heartburn symptoms
Heartburn symptoms will be collected by participant diaries.
Time frame: Week 4
Severity of heartburn symptoms
Heartburn symptoms will be collected by participant diaries.
Time frame: Week 4
Heartburn symptoms stratified by response (improvement or non-improvement) at Week 2
Heartburn symptoms will be collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate, and severity of heartburn symptoms are evaluation parameters.
Time frame: Week 4
Heartburn Symptoms Stratified by Baseline Endoscopic Findings (Grade N or M)
Heartburn symptoms collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate and severity of heartburn symptoms=evaluation parameters. Participants with Non-Erosive Gastroesophageal Reflux Disease divided into Grade N (endoscopically normal) and M (minimal change) by modified Los Angeles Classification System. Grade definitions: Grade N (endoscopically normal), M (minimal change), A (Mucosal break \<5 mm) B (Mucosal break ≥5 mm) C (Mucosal break continuous between 2 or more folds and \<75% of circumference) and D (Mucosal break ≥75% of circumference).
Time frame: Week 4
Heartburn symptoms stratified by combination of response at Week 2 and baseline endoscopic findings (improvement and grade N, improvement and grade M, non-improvement and grade N, non-improvement and grade M.)
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Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Abiko-shi, Chiba, Japan
Unnamed facility
Kashiwa-shi, Chiba, Japan
Unnamed facility
Noda, Chiba, Japan
Unnamed facility
Yachiyo-shi, Chiba, Japan
Unnamed facility
Saijo-shi, Ehime, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Itoshima-shi, Fukuoka, Japan
Unnamed facility
Kasuya-gun, Fukuoka, Japan
Unnamed facility
Onga-gun, Fukuoka, Japan
...and 42 more locations
Heartburn symptoms will be collected by participant diaries. Percentage of symptom-free days, cumulative symptom improvement rate, and severity of heartburn symptoms are evaluation parameters.
Time frame: Week 4