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Trial record 16 of 2418 for:    gynecology

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00150280
First Posted: September 8, 2005
Last Update Posted: July 25, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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
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
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

ClinicalTrials.gov Identifier: NCT00150280     History of Changes
Other Study ID Numbers: A3191086
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: July 25, 2006
Last Verified: November 2005

Additional relevant MeSH terms:
Acute Pain
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
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