Effect of Celecoxib Versus Placebo Before and After Knee Surgery on the Overall Use of Analgesics After Surgery
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthroscopy
Intervention: Celecoxib (Drug); Placebo (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
To compare the total analgesic use at 24 hours after arthroscopic knee surgery in patients
treated with celecoxib versus placebo.
Clinical Details
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 design: Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Primary outcome: Total analgesic use after surgery
Secondary outcome: Physical examinationNumber and percentage of subjects taking analgesic (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery Time to analgesic use after surgery Cumulative number of HC/APAP tablets taken after first dose of study medication Vital signs Patient's Assessment of Knee Pain, according to visual analogue scale at rest and with movement after surgery Change in volumetric measurement of both knees from prior to surgery Patient Treatment Satisfaction Scales after surgery Adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Pfizer Investigational Site, PHOENIX, Arizona 85023, United States
Pfizer Investigational Site, ST. PETERSBURG, Florida 33713, United States
Pfizer Investigational Site, BALTIMORE, Maryland 21218, United States
Pfizer Investigational Site, SPRINGFIELD, Massachusetts 01199, United States
Pfizer Investigational Site, SPRINGFIELD, Missouri 65804, United States
Pfizer Investigational Site, COLUMBIA, South Carolina 29204, United States
Pfizer Investigational Site, Johnson City, Tennessee 37601, United States
Pfizer Investigational Site, San Antonio, Texas 78229, United States
Pfizer Investigational Site, CHARLOTTESVILLE, Virginia 22908-0159, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: February 2003
Ending date: August 2003
Last updated: March 11, 2008
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