Post Operative Pain
Conditions
Keywords
Celecoxib, Celecox, Pain, Surgery, NSAIDs
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.
Interventions
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient impressions (4-categorical assessments) | For 2 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed