Effect of Celecoxib Versus Placebo Before and After Knee Surgery on 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: Placebo (Other); Celecoxib (Drug)
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 total analgesic use at 24 hours after arthroscopic knee surgery in
celecoxib-treated versus placebo-treated patients
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 (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery
Secondary outcome: Patient Assessment of Pain, according to visual analogue scale, after surgery at rest and flexionTime to analgesic use after surgery Number and percentage of patients taking HC/APAP after surgery Adverse events Physical exam Vital signs Laboratory evaluation
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Pfizer Investigational Site, Phoenix, Arizona 85023, United States
Pfizer Investigational Site, ST. PETERSBURG, Florida 33713, United States
Pfizer Investigational Site, St. Petersburg, Florida 33713, United States
Pfizer Investigational Site, BALTIMORE, Maryland 21218, United States
Pfizer Investigational Site, Timonium, Maryland 21093, United States
Pfizer Investigational Site, SPRINGFIELD, Massachusetts 01109, United States
Pfizer Investigational Site, Springfield, Massachusetts 01104, United States
Pfizer Investigational Site, Springfield, Massachusetts 01107, United States
Pfizer Investigational Site, Springfield, Massachusetts 01199, United States
Pfizer Investigational Site, Springfield, Missouri 65807, United States
Pfizer Investigational Site, COLUMBIA, South Carolina 29204, United States
Pfizer Investigational Site, Columbia, South Carolina 29212, United States
Pfizer Investigational Site, Columbia, South Carolina 29202, United States
Pfizer Investigational Site, Orangeburg, South Carolina 29110, United States
Pfizer Investigational Site, Johnson City, Tennessee 37601, United States
Pfizer Investigational Site, San Antonio, Texas 78205, United States
Pfizer Investigational Site, San Antonio, Texas 78209, United States
Pfizer Investigational Site, San Antonio, Texas 78229, United States
Pfizer Investigational Site, San Antonio, Texas 78240, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2004
Ending date: June 2004
Last updated: March 4, 2008
|
