Effect of Celecoxib Versus Placebo Before and After Knee Surgery on the Overall Use of Analgesics After Surgery - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00633386

Purpose

To compare the total analgesic use at 24 hours after arthroscopic knee surgery in patients treated with celecoxib versus placebo.

Condition	Intervention	Phase
Arthroscopy	Drug: Celecoxib Other: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, Randomized, Comparison Study of the Efficacy of Celebrex 400 mg Single Dose Pre and Celebrex 200 mg Post Ambulatory Arthroscopic Knee Surgery for Total Analgesic Use After Surgery

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Total analgesic use after surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physical examination [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
Number and percentage of subjects taking analgesic (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery [ Time Frame: 1, 2, 6, 8, 10, 12, 24, and 36 hours ] [ Designated as safety issue: No ]
Time to analgesic use after surgery [ Time Frame: 1, 2, 6, 8, 10, 12, 24, and 36 hours ] [ Designated as safety issue: No ]
Cumulative number of HC/APAP tablets taken after first dose of study medication [ Time Frame: 1, 2, 6, 8, 10, 12, 36 hours and Day 2 ] [ Designated as safety issue: No ]
Vital signs [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
Patient's Assessment of Knee Pain, according to visual analogue scale at rest and with movement after surgery [ Time Frame: 1, 2, 6, 8, 10, 12, 24 and 36 hours ] [ Designated as safety issue: No ]
Change in volumetric measurement of both knees from prior to surgery [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Patient Treatment Satisfaction Scales after surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]

Enrollment:	200
Study Start Date:	February 2003
Study Completion Date:	August 2003

Arms	Assigned Interventions
A: Experimental	Drug: Celecoxib 400 mg oral capsule as a single dose 1 hour prior to surgery and 200 mg oral capsule as a single dose as needed post-surgery
B: Placebo Comparator	Other: Placebo Matched placebo

Eligibility

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

Criteria

Inclusion criteria:

Diagnosed knee meniscus pathology requiring ambulatory arthroscopic meniscectomy or partial meniscectomy
Willing to participate in study for 36 hours and come to follow-up visit 7 days post-surgery

Exclusion criteria:

Osteoarthritis, inflammatory arthritis, or previous fracture of index joint
Received acetaminophen or low-dose narcotic within 8 hours of surgery
Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or soft-tissue (2 months) injections of corticosteroids of the first dose of study medication or received intra-articular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633386

Locations

United States, Arizona
Pfizer Investigational Site
PHOENIX, Arizona, United States, 85023
United States, Florida
Pfizer Investigational Site
ST. PETERSBURG, Florida, United States, 33713
United States, Maryland
Pfizer Investigational Site
BALTIMORE, Maryland, United States, 21218
United States, Massachusetts
Pfizer Investigational Site
SPRINGFIELD, Massachusetts, United States, 01199
United States, Missouri
Pfizer Investigational Site
SPRINGFIELD, Missouri, United States, 65804
United States, South Carolina
Pfizer Investigational Site
COLUMBIA, South Carolina, United States, 29204
United States, Tennessee
Pfizer Investigational Site
Johnson City, Tennessee, United States, 37601
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
Pfizer Investigational Site
CHARLOTTESVILLE, Virginia, United States, 22908-0159

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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

No publications provided

Responsible Party:	Pfizer, Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191066
Study First Received:	March 4, 2008
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00633386 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Pfizer:

Knee Surgery
Arthroscopic Surgery

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Sensory System Agents

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

ClinicalTrials.gov processed this record on February 08, 2010