A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients
- Registration Number
- NCT01118572
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 616
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description etodolac group etodolac - placebo group Placebo - YM177 group YM177 -
- Primary Outcome Measures
Name Time Method Patient impressions (4-categorical assessments) For 2 days
- Secondary Outcome Measures
Name Time Method Pain intensity For 2 days Pain intensity difference For 2 days Discontinuation due to insufficient efficacy For 2 days Safety assessed by AE, clinical lab tests and vital signs For 2 days