Clinical trial NCT00643799: Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis
Official title: A Randomized, Multicenter, Double-Blind, Double-Dummy Study Comparing the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Naproxen 500 mg Twice Daily in the 6-month 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: 2008-03-26
Enrollment: 586
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 naproxen for the treatment of knee osteoarthritis


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit
* Functional Capacity Classification of I-III

Exclusion Criteria:

* Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
* Received acetaminophen within 24 hours of the baseline visit
* Acute joint trauma at index joint within the past 3 months with active symptoms
* History of gastrointestinal (GI) perforation, obstruction, or bleeding
* Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
* Received corticosteroids or hyaluronic acid within certain timeframe before study

Primary outcomes:
measure: Number of responders, defined as a 20% improvement from baseline in the The Western Ontario MacMaster (WOMAC)Questionnaire Total Score
timeFrame: Month 6
Secondary outcomes:
measure: Number of health care professional contacts
timeFrame: Throughout study
measure: Patient's and Physician's Satisfaction with Current Arthritis Therapy
timeFrame: Month 6
measure: Change in WOMAC Total Score from baseline
timeFrame: Month 6
measure: Change in WOMAC Subscales from baseline
timeFrame: Month 6
measure: Response in each WOMAC Subscale
timeFrame: Month 6
measure: Change in Medical Outcome Study sleep scale from baseline
timeFrame: Month 6
measure: Laboratory tests
timeFrame: Month 6
measure: Vital signs
timeFrame: Month 6
measure: Response in VAS
timeFrame: Month 6
measure: Change in Patient's and Physician's Global Assessment of Pain from baseline
timeFrame: Month 6
measure: Change in visual analog scale (VAS) from baseline
timeFrame: Month 6
measure: Adverse events
timeFrame: Throughout study
measure: Change in Gastrointestinal (GI) Distress Scale from Week 1
timeFrame: Month 6
measure: Change in GI Distress Scale from time of discontinuation of study drug
timeFrame: Month 6
measure: Receipt of prescription or over-the-counter gastroprotective agents or pain medications (off study drug)
timeFrame: Throughout study
measure: Number of hospitalizations, emergency room visits, and procedures
timeFrame: Throughout study
measure: Change in Work Limitation Questionnaire scale scores from baseline
timeFrame: Month 6
measure: Physical examination
timeFrame: Month 6
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Buena Park
country: United States
facility: Pfizer Investigational Site
state: California
city: Paramount
country: United States
facility: Pfizer Investigational Site
state: California
city: Rancho Mirage
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Zephyrhills
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Rockford
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Covington
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Clinton
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Greenbelt
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Hagerstown
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Wheaton
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Lansing
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Flowood
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Beachwood
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Bethlehem
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Media
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Angelo
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: