Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.
To verify the superiority to placebo and the noninferiority to etodolac of YM177 in terms of efficacy assessment in patients with postoperative pain. Also, to compare them in terms of safety assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
616
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kantou, Japan
Patient impressions (4-categorical assessments)
Time frame: For 2 days
Pain intensity
Time frame: For 2 days
Pain intensity difference
Time frame: For 2 days
Discontinuation due to insufficient efficacy
Time frame: For 2 days
Safety assessed by AE, clinical lab tests and vital signs
Time frame: For 2 days
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Unnamed facility
Kyusyu, Japan
Unnamed facility
Shikoku, Japan
Unnamed facility
Tōhoku, Japan