A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients

A Phase III Study of YM177 (Postoperative Pain) -- An Etodolac- and Placebo-controlled, Multicenter, Double-blind, Group Comparison Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients --

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.

Inclusion Criteria:

• Patients with spontaneous pain within 24 hours postoperatively

• The intensity of the pain:

  • 4-categorical assessment: "Moderate pain" or "Severe pain"
  • VAS assessment: 45.0 mm or higher

• Patients whose postoperative pain can be managed using an oral NSAID

Exclusion Criteria:

• A past history of aspirin-induced asthma
• A past of ischemic heart disease, serious arrhythmia, congestive heart failure or cerebrovascular disease
• Patients who undergoes the surgical procedure under general anesthesia
• Patients taking excluded medications