Compare Celecoxib and Ibuprofen Sr In The Management Of Acute Pain Post Orthopedic Or Gynecological Surgery
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: celecoxib and ibuprofen SR (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To validate the analgesic efficacy and safety of celecoxib compared with ibuprofen SR in the
management of acute pain post orthopedic or gynecological surgery
Clinical Details
Official title: A Prospective, Randomized, Double-Blind, Double-Dummy, Multi-Center Study Comparing Celecoxib and Ibuprofen Sr In The Management Of Acute Pain Post Orthopedic Or Gynecological Surgery
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To validate the analgesic efficacy of celecoxib compared with ibuprofen SR in the management of acute pain post orthopedic or gynecological surgery
Secondary outcome: To validate safety of celecoxib compared with ibuprofen SR in the management of acute pain post orthopedic or gynecological surgery
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Undergone uncomplicated orthopedic surgery or abdominal gynecological surgery under
epidural anesthesia
- Baseline pain intensity of more than 45 mm as measured by VAS and a severity of pain
graded as moderate or severe on the categorical pain intensity scale
Exclusion Criteria:
- A previous history of intolerance or hypersensitivity to any NSAIDs, cyclooxygenase
inhibitor, sulfonamides, or any analgesic, or to drugs with similar chemical
structures
Locations and Contacts
Pfizer Investigational Site, Beijing 100034, China
Pfizer Investigational Site, Beijing 100083, China
Pfizer Investigational Site, Beijing 100020, China
Pfizer Investigational Site, Shanghai 200025, China
Pfizer Investigational Site, Shanghai 200032, China
Pfizer Investigational Site, Shenyang, Liaoning Province 110001, China
Additional Information
Starting date: October 2004
Ending date: July 2005
Last updated: July 23, 2006
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