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

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ClinicalTrials.gov Identifier: NCT00150280
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Brief 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

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: celecoxib and ibuprofen SR Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : October 2004
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  1. To validate safety of celecoxib compared with ibuprofen SR in the management of acute pain post orthopedic or gynecological surgery


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150280


Locations
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China, Liaoning
Pfizer Investigational Site
Shenyang, Liaoning, China, 110001
China
Pfizer Investigational Site
Beijing, China, 100020
Pfizer Investigational Site
Beijing, China, 100034
Pfizer Investigational Site
Beijing, China, 100083
Pfizer Investigational Site
Shanghai, China, 200025
Pfizer Investigational Site
Shanghai, China, 200032
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT00150280    
Other Study ID Numbers: A3191086
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ibuprofen
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors