The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
343
20mg once daily oral
once daily oral
Research Site
Chiryū, Aichi-ken, Japan
Research Site
Seto, Aichi-ken, Japan
Research Site
Yotukaido, Chiba, Japan
Research Site
Miyaodai, Fukuoka, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Akashi, HYOGOi, Japan
Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
The absence of gastric and/or duodenal ulcer throughout the treatment period
Time frame: each visit up to 24 weeks
Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment
Time frame: up to 4 weeks
Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment
Time frame: up to 12 weeks
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Research Site
Itami, Hyōgo, Japan
Research Site
Koto, Hyōgo, Japan
Research Site
Nishinomiya, Hyōgo, Japan
Research Site
Hitachi, Ibaragi, Japan
...and 29 more locations