The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
395
Esomeprazole 20 mg once daily
Research Site
Ōita, Japan
Research Site
Saitama, Japan
Research Site
Tokyo, Japan
Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period
Time frame: up to 52 weeks
Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
Time frame: up to 4 weeks after treatment
Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
Time frame: up to 12 weeks after treatment
Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment
Time frame: up to 24 weeks after treatment
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