The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
540
10mg once daily oral administration
20mg once daily oral administration
10mg once daily oral administration
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.
Time frame: Up to 24 weeks
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.
Time frame: up to 4 weeks
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.
Time frame: Up to 12 weeks
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Research Site
Akita, Akita, Japan
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Kashiwa, Chiba, Japan
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Kisarazu, Chiba, Japan
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Kōriyama, Fukishima, Japan
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Nihonmatsu, Fukishima, Japan
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Nishishirakawa, Fukishima, Japan
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Fukuoika, Fukuoka, Japan
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Fukuoka, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Nukaya, Fukuoka, Japan
...and 34 more locations