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

Astellas

Status and phase: Completed; Phase 3

Conditions: Post Operative Pain

Treatments: Drug: YM177; Drug: etodolac; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01118572

177-CL-102

Details and patient eligibility

About

Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.

Full description

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.

Enrollment: 616 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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616 participants in 3 patient groups, including a placebo group

YM177 group

Experimental group

Treatment:

Drug: YM177

etodolac group

Active Comparator group

Treatment:

Drug: etodolac

placebo group

Placebo Comparator group

Treatment:

Drug: Placebo