Effect of Celecoxib Versus Placebo Before and After Knee Surgery on the Overall Use of Analgesics After Surgery

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. Identifier: NCT00633386
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : March 13, 2009
Information provided by:

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

Condition or disease Intervention/treatment Phase
Arthroscopy Drug: Celecoxib Other: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2003
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A 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
Placebo Comparator: B Other: Placebo
Matched placebo

Primary Outcome Measures :
  1. Total analgesic use after surgery [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Physical examination [ Time Frame: Day 7 ]
  2. 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 ]
  3. Time to analgesic use after surgery [ Time Frame: 1, 2, 6, 8, 10, 12, 24, and 36 hours ]
  4. 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 ]
  5. Vital signs [ Time Frame: Day 7 ]
  6. 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 ]
  7. Change in volumetric measurement of both knees from prior to surgery [ Time Frame: Day 7 ]
  8. Patient Treatment Satisfaction Scales after surgery [ Time Frame: 24 hours ]
  9. Adverse events [ Time Frame: Day 7 ]

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

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

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 identifier (NCT number): NCT00633386

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
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT00633386     History of Changes
Other Study ID Numbers: A3191066
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009

Keywords provided by Pfizer:
Knee Surgery
Arthroscopic Surgery

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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