The subjects will be patients who are anticipated to develop postoperative pain that is determined manageable with oral NSAIDs
Conditions
Interventions
celecoxib (400 mg only for the first administration on the start day of treatment, and thereafter at a 200 mg, twice daily for 3 days)
loxoprofen (at a 60 mg, three times daily for 3 days)
Sponsors
Nippon Medical School Department of Orthopaedic Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women aged 20 to 64 years at the time of providing informed consent 2) Inpatient and outpatient 3) Patients whose postoperative pain is determined by the investigator to be manageable with oral NSAIDs 4) Patients who is capable of providing written voluntary consent for study participation and adhering to the protocol.
Exclusion criteria
Exclusion criteria: 1)Patients requiring long-acting anesthesia, epidural anesthesia or patient control analgesia (PCA) 2) Patients who are on antithrombotic treatment 3) Patients with a past or current history of aspirin-induced asthma 4) Patients with a past or current history of hypersensitivity to NSAIDs or sulfonamide (sulfa drugs) 5)Patients with concurrent gastrointestinal bleeding or peptic ulcer 6) Patients with a past or current history of ischemic heart disease (angina pectoris or myocardial infarction), serious arrhythmia, congestive heart failure and cerebrovascular disorder (cerebral infarction, transient ischemic attack, cerebral hemorrhage or subarachnoid hemorrhage). Patients with a history of revascularization (coronary artery, carotid artery, cerebral artery, renal artery, aorta or peripheral artery) 7) Patients with serious complications 8) Women who are pregnant, lactating or possibly pregnant or wishing to become pregnant during the study period. 9) Patients with serious liver or renal disorder, cardiac disease or abnormal blood disease 10) Patients who are determined by the investigator/subinvestigator to be not suitable for the study due to other reasons
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| (1)Time to analgesic effect after the first administration (2)Time to disappearance of analgesic effect after the first administration (3)Changes in the VAS from baseline (1, 2 and 3 hours after study drug administration and Day 2 before breakfast) (4)Change in the VAS from baseline after study treatment completion (Days 4 and 5 before breakfast) | — |
Primary
| Measure | Time frame |
|---|---|
| Change in the VAS on the morning of postoperative Day 3 from baseline Evaluation method | — |
Countries
Japan
Contacts
Public ContactNorishige Iizawa
Nippon Medical School Orthopaedic surgery
Outcome results
None listed