A clinical study on the efficacy of celecoxib in patients with postoperative pain (A multicenter, randomized, open-label,parallel-group controlled study of celecoxib vs. loxoprofen)
- Conditions
- The subjects will be patients who are anticipated to develop postoperative pain that is determined manageable with oral NSAIDs
- Registration Number
- JPRN-UMIN000011302
- Lead Sponsor
- ippon Medical School Department of Orthopaedic Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 230
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the VAS on the morning of postoperative Day 3 from baseline Evaluation method
- Secondary Outcome Measures
Name Time Method (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)