Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain

This study has been completed.

First Received: August 31, 2005 Last Updated: April 14, 2008 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00143169

Purpose

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.

Condition	Intervention	Phase
Pain, Postoperative	Drug: Parecoxib and placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Parecoxib Parecoxib sodium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 Measures:

To validate safety of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.

Estimated Enrollment:	220
Study Start Date:	September 2004
Estimated Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143169

Locations

China
Pfizer Investigational Site
Beijing, China, 100034
Pfizer Investigational Site
Beijing, China, 100083
Pfizer Investigational Site
Beijing, China, 100020
Pfizer Investigational Site
Shanghai, China, 200025
Pfizer Investigational Site
Shanghai, China, 200032
China, Guangdong Province
Pfizer Investigational Site
Guangzhou, Guangdong Province, China, 510080
China, Liaoning Province
Pfizer Investigational Site
Shenyang, Liaoning Province, China, 110001
China, Shandong Province
Pfizer Investigational Site
Qingdao, Shandong Province, China, 266011

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

Link to ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A3481004
Study First Received:	August 31, 2005
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00143169 History of Changes
Health Authority:	China: State Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Parecoxib
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Pain
Enzyme Inhibitors
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes

Postoperative Complications
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pain, Postoperative

ClinicalTrials.gov processed this record on February 08, 2010