Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 01, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Parecoxib and placebo (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 morphine-sparing effect and safety of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.
Clinical Details
Official title:
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Of Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain Following Orthopedic Or Gynecological Surgery
Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To validate the morphine-sparing effect of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.
Secondary outcome: To validate safety of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Undergo gynecological or orthopedic surgery under epidural anesthesia
Exclusion Criteria:
- A previous history of intolerance or hypersensitivity to any NSAID, cyclooxygenase-2 selective inhibitors, sulphonamides, or any of the excipients of parecoxib.
Locations and Contacts
Pfizer Investigational Site, Guangzhou, Guangdong Province 510080, China
Pfizer Investigational Site, Beijing 100020, China
Pfizer Investigational Site, Beijing 100083, China
Pfizer Investigational Site, Shanghai 200025, China
Pfizer Investigational Site, Shanghai 200032, China
Pfizer Investigational Site, Beijing 100034, China
Pfizer Investigational Site, Shenyang, Liaoning Province 110001, China
Pfizer Investigational Site, Qingdao, Shandong Province 266011, China
Additional Information
Starting date:
September 2004
Ending date: June 2005
Last updated: July 23, 2006
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