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

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

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Shenyang, Liaoning, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

celecoxib and ibuprofen SR

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2004
Study completion: 2005
First posted: Sep 8, 2005
Registry last updated: Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed