Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee

Condition(s) targeted: Osteoarthritis, Knee

Intervention: Ibuprofen (Drug); Celecoxib (Drug); Placebo (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

To compare the efficay and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in patient's assessment of arthritis pain according to visual analogue scale (VAS)

Secondary outcome:

Vital signs

Physical examination

Laboratory test results

Adverse events

Change from baseline in patient's and physician's global assessment of pain

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index

Pain Satisfaction Scale

Patient Health Questionnaire (PHQ-9)

Change from baseline in patient's assessment of arthritis pain according to VAS

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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

Pfizer Investigational Site, ANNISTON, Alabama 36207, United States

Pfizer Investigational Site, PHOENIX, Arizona 85051, United States

Pfizer Investigational Site, ANAHEIM, California 92804, United States

Pfizer Investigational Site, PARAMOUNT, California 90723, United States

Pfizer Investigational Site, SAN DIEGO, California 92108, United States

Pfizer Investigational Site, Long Beach, California 90806, United States

Pfizer Investigational Site, NAPLES, Florida 34102, United States

Pfizer Investigational Site, St Petersburg, Florida 33710, United States

Pfizer Investigational Site, PEMBROKE PINES, Florida 33024, United States

Pfizer Investigational Site, MIAMI, Florida 33186, United States

Pfizer Investigational Site, DELAND, Florida 32720, United States

Pfizer Investigational Site, CHICAGO, Illinois 60610, United States

Pfizer Investigational Site, EVANSVILLE, Indiana 47712, United States

Pfizer Investigational Site, LAS VEGAS, Nevada 89102, United States

Pfizer Investigational Site, EDISON, New Jersey 08817, United States

Pfizer Investigational Site, South Plainfield, New Jersey 07080, United States

Pfizer Investigational Site, ALBUQUERQUE, New Mexico 87109, United States

Pfizer Investigational Site, BROOKLYN, New York 11203, United States

Pfizer Investigational Site, NEW YORK, New York 10022-1009, United States

Pfizer Investigational Site, COLUMBUS, Ohio 43124, United States

Pfizer Investigational Site, CINCINNATI, Ohio 45242, United States

Pfizer Investigational Site, TULSA, Oklahoma 74136, United States

Pfizer Investigational Site, JENKINTOWN, Pennsylvania 19046, United States

Pfizer Investigational Site, ALTOONA, Pennsylvania 16601, United States

Pfizer Investigational Site, NEWTOWN, Pennsylvania 18940, United States

Pfizer Investigational Site, Warwick, Rhode Island 02886, United States

Pfizer Investigational Site, GREER, South Carolina 29651, United States

Pfizer Investigational Site, CHARLESTON, South Carolina 29407, United States

Pfizer Investigational Site, MOUNT PLEASANT, South Carolina 29464, United States

Pfizer Investigational Site, JOHNSON CITY, Tennessee 37601, United States

Pfizer Investigational Site, DALLAS, Texas 75235, United States

Pfizer Investigational Site, LAYTON, Utah 84041, United States

Pfizer Investigational Site, DANVILLE, Virginia 24541, United States

To obtain contact information for a study center near you, click here.

Starting date: October 2002
Ending date: March 2003
Last updated: February 12, 2008