Clinical trial NCT00640627: Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and Ibuprofen
Official title: A Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Once Daily Celebrex® (Celecoxib) vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee Non-Responsive to Naproxen and Ibuprofen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 380
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 safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen


Eligibility criteria: Inclusion criteria:

* OA of the knee in flare state at baseline visit and functional capacity class of I-III
* Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability

Exclusion criteria:

* Inflammatory arthritis or gout/pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
* Received acetaminophen within 24 hours of baseline visit
* Use of mobility assisting device for less than six weeks prior to study screening or use of a walker
* History of gastrointestinal (GI) perforation, obstruction, or bleeding
* Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
* Recieved corticosteroids or hyaluronic acid within certain timeframe before study

Primary outcomes:
measure: Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS)
timeFrame: Week 6
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: Week 6
measure: Patient's and Physician's Global Assessment of Pain
timeFrame: Weeks 2 and 6
measure: The Medical Outcomes Study Sleep Scale
timeFrame: Week 6
measure: Adverse events
timeFrame: Weeks 0-6
measure: Laboratory tests
timeFrame: Week 6
measure: Vital signs
timeFrame: Week 6
measure: Physical examination
timeFrame: Week 6
measure: Patient's Assessment of Arthritis Pain according to VAS
timeFrame: Week 2
measure: Serious adverse events
timeFrame: Up to 30 days after last dose
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Long Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: Paramount
country: United States
facility: Pfizer Investigational Site
state: California
city: Tustin
country: United States
facility: Pfizer Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: DeLand
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: Woodstock
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Flowood
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Chesterfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Reno
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Mason
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Beaver
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Camp Hill
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Jenkintown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Greensboro
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Johnson City
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Murfreesboro
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: