Compare Celecoxib and Ibuprofen Sr In The Management Of Acute Pain Post Orthopedic Or Gynecological Surgery

This study has been completed.

First Received on September 6, 2005. Last Updated on July 23, 2006 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00150280

Purpose

To validate the analgesic efficacy and safety of celecoxib compared with ibuprofen SR in the management of acute pain post orthopedic or gynecological surgery

Condition	Intervention	Phase
Pain, Postoperative	Drug: celecoxib and ibuprofen SR	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Ibuprofen Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To validate the analgesic efficacy of celecoxib compared with ibuprofen SR in the management of acute pain post orthopedic or gynecological surgery

Secondary Outcome Measures:

To validate safety of celecoxib compared with ibuprofen SR in the management of acute pain post orthopedic or gynecological surgery

Estimated Enrollment:	132
Study Start Date:	October 2004
Estimated Study Completion Date:	July 2005

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150280

Locations

China, Liaoning Province
Pfizer Investigational Site
Shenyang, Liaoning Province, China, 110001
China
Pfizer Investigational Site
Beijing, China, 100034
Pfizer Investigational Site
Beijing, China, 100083
Pfizer Investigational Site
Beijing, China, 100020
Pfizer Investigational Site
Shanghai, China, 200032
Pfizer Investigational Site
Shanghai, China, 200025

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00150280 History of Changes
Other Study ID Numbers:	A3191086
Study First Received:	September 6, 2005
Last Updated:	July 23, 2006
Health Authority:	China: State Food and Drug Administration

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ibuprofen
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012