Clinical trial NCT00633438: Effect of Celecoxib Versus Placebo Before and After Knee Surgery on 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: 204
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 total analgesic use at 24 hours after arthroscopic knee surgery in celecoxib-treated versus placebo-treated patients


Eligibility 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

Primary outcomes:
measure: Total analgesic use (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Patient Assessment of Pain, according to visual analogue scale, after surgery at rest and flexion
timeFrame: 1, 2, 6, 8, 10, 12, 24, 36 hours
measure: Time to analgesic use after surgery
timeFrame: 1, 2, 6, 8, 10, 12, 24, 36 hours
measure: Number and percentage of patients taking HC/APAP after surgery
timeFrame: 1, 2, 6, 8, 10, 12, 24, 36 hours
measure: Adverse events
timeFrame: Day 7
measure: Physical exam
timeFrame: Day 7
measure: Vital signs
timeFrame: Day 7
measure: Laboratory evaluation
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: Timonium
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: Massachusetts
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
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: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Orangeburg
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: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: