Clinical trial NCT00620867: Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)
Official title: A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 393
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.


Eligibility criteria: Inclusion Criteria:

* Aged \>= 40 years old
* Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
* Functional capacity class of I-III

Exclusion Criteria:

* Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
* Acute joint trauma at index joint within the past 3 months with active symptoms
* Score of \>=20 on PHQ-9 or score of \>=1 on PHQ-9 item i
* Use of mobility assisting device for \<6 weeks or use of walker

Primary outcomes:
measure: Change from baseline in patient's assessment of arthritis pain according to visual analogue scale (VAS)
timeFrame: Week 6
Secondary outcomes:
measure: Vital signs
timeFrame: Weeks 2 and 6
measure: Physical examination
timeFrame: Week 6
measure: Laboratory test results
timeFrame: Week 6
measure: Adverse events
timeFrame: Weeks 2 and 6
measure: Change from baseline in patient's and physician's global assessment of pain
timeFrame: Weeks 2 and 6
measure: Pain Satisfaction Scale
timeFrame: Days 1-7
measure: Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: Week 6
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Week 6
measure: Change from baseline in patient's assessment of arthritis pain according to VAS
timeFrame: Week 2
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Paramount
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Naples
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Edison
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: South Plainfield
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Altoona
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Jenkintown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Newtown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Johnson City
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Layton
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Danville
country: United States
facility: Pfizer Investigational Site
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: