Clinical trial NCT00638807: Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients 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: 2008-03-19
Enrollment: 388
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 placebo for the treatment of knee osteoarthritis (OA) in patients who were unresponsive to prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen


Eligibility criteria: Inclusion Criteria:

Inclusion criteria:

* Diagnosed, active, and symptomatic OA of the knee in a flare state with a functional capacity class of I-III at baseline visit
* 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:

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 the baseline visit
* Use of a 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
* Received 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: Patient's Assessment of Arthritis Pain, according to VAS
timeFrame: Week 2
measure: The Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: Week 6
measure: Patient's and Physician's Global Assessment of Arthritis
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: Serious adverse events
timeFrame: Up to 30 days after last dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Buena Park
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: Longwood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Zephyrhills
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Boise
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Morton Grove
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: Wheaton
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Bozeman
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Trenton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Binghamton
country: United States
facility: Pfizer Investigational Site
state: New York
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: Cary
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Bismarck
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Johnstown
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: New Tazewell
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
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: