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

Purpose

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

Condition	Intervention	Phase
Arthroscopy	Other: Placebo Drug: Celecoxib	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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:

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Total analgesic use (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Assessment of Pain, according to visual analogue scale, after surgery at rest and flexion [ Time Frame: 1, 2, 6, 8, 10, 12, 24, 36 hours ] [ Designated as safety issue: No ]
Time to analgesic use after surgery [ Time Frame: 1, 2, 6, 8, 10, 12, 24, 36 hours ] [ Designated as safety issue: No ]
Number and percentage of patients taking HC/APAP after surgery [ Time Frame: 1, 2, 6, 8, 10, 12, 24, 36 hours ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
Physical exam [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
Laboratory evaluation [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]

Enrollment:	204
Study Start Date:	January 2004
Study Completion Date:	June 2004

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

Eligibility

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

Criteria

Inclusion Criteria:

Inclusion criteria:

Diagnosed (or suspected to have) meniscus trauma of the knee requiring ambulatory arthroscopic knee surgery
Willing to participate in study for 36 hours and come to follow-up visit 7 days post surgery

Exclusion Criteria:

Exclusion criteria:

Osteoarthritis, inflammatory arthritis, or previous fracture of index joint
Received acetaminophen or low dose narcotic (vicodin/tylox) 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 intra-artcular 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: NCT00633438

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
Pfizer Investigational Site
Timonium, Maryland, United States, 21093
United States, Massachusetts
Pfizer Investigational Site
Springfield, Massachusetts, United States, 01109
Pfizer Investigational Site
Springfield, Massachusetts, United States, 01104
Pfizer Investigational Site
Springfield, Massachusetts, United States, 01107
Pfizer Investigational Site
Springfield, Massachusetts, United States, 01199
United States, Missouri
Pfizer Investigational Site
Springfield, Missouri, United States, 65807
United States, South Carolina
Pfizer Investigational Site
Columbia, South Carolina, United States, 29204
Pfizer Investigational Site
Columbia, South Carolina, United States, 29212
Pfizer Investigational Site
Columbia, South Carolina, United States, 29202
Pfizer Investigational Site
Orangeburg, South Carolina, United States, 29110
United States, Tennessee
Pfizer Investigational Site
Johnson City, Tennessee, United States, 37601
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78205
Pfizer Investigational Site
San Antonio, Texas, United States, 78209
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
San Antonio, Texas, United States, 78240

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

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier:	NCT00633438 History of Changes
Other Study ID Numbers:	A3191067
Study First Received:	March 4, 2008
Last Updated:	March 12, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Knee Surgery Arthroscopic Surgery

Additional relevant MeSH terms:

Analgesics
Celecoxib
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013