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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)

Not Applicable
Suspended
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
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in the VAS on the morning of postoperative Day 3 from baseline Evaluation method
Secondary Outcome Measures
NameTimeMethod
(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)
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