Clinical trial NCT00633386: Effect of Celecoxib Versus Placebo Before and After Knee Surgery on the Overall Use of Analgesics After Surgery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroscopy
Keywords: Knee Surgery
Arthroscopic Surgery
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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

Primary outcomes:
measure: Total analgesic use after surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Physical examination
timeFrame: Day 7
measure: Number and percentage of subjects taking analgesic (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery
timeFrame: 1, 2, 6, 8, 10, 12, 24, and 36 hours
measure: Time to analgesic use after surgery
timeFrame: 1, 2, 6, 8, 10, 12, 24, and 36 hours
measure: Cumulative number of HC/APAP tablets taken after first dose of study medication
timeFrame: 1, 2, 6, 8, 10, 12, 36 hours and Day 2
measure: Vital signs
timeFrame: Day 7
measure: Patient's Assessment of Knee Pain, according to visual analogue scale at rest and with movement after surgery
timeFrame: 1, 2, 6, 8, 10, 12, 24 and 36 hours
measure: Change in volumetric measurement of both knees from prior to surgery
timeFrame: Day 7
measure: Patient Treatment Satisfaction Scales after surgery
timeFrame: 24 hours
measure: Adverse events
timeFrame: Day 7
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Saint Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Johnson City
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: