To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
875
24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind celecoxib 200 mg daily. Placebo used as flare medication when directed.
24 weeks of study treatment: 2 weeks open-label celecoxib 200 mg daily followed by 22 weeks of randomized double blind placebo daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
Number of Flare Events Per Time of Exposure to Study Medication
Number of flare events per month during Period III (calculated as number of flares divided by number of months participant was enrolled during Period III). Flare was determined using pre-defined criteria, using an interactive voice response system.
Time frame: Period III (22 weeks)
Time to Occurrence of First Osteoarthritis (OA) Flare
Time from first dose of double blind medication (start of Period III) to occurrence of first OA flare. Flare was determined using pre-defined criteria, using an interactive voice response system
Time frame: Period III (22 weeks)
Proportion of Days Free From Osteoarthritis (OA) Flare
Number of days subject was free from OA flare divided by number of days on study medication in Period III. Flare was determined using pre-defined criteria, using an interactive voice response system.
Time frame: Period III (22 weeks)
Proportion of Days in Osteoarthritis (OA) Flare
Number of days subject was in OA flare divided by number of days on study medication in Period III. Subjects may have more than one flare. Flare was determined using pre-defined criteria, using an interactive voice response system.
Time frame: Period III (22 weeks)
Arthritis Pain Numerical Rating Scale (NRS)
Participant rated intensity of osteoarthritis pain on categorical scale from 0 (no pain) to 10 (worst pain). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.
Time frame: Period III
Patient's Global Assessment of Arthritis
Participant's response to question "Considering all the ways the osteoarthritis in your hip or knee affects you, how are you doing today?" on scale from 1 (very good) to 5 (very poor). Scores analyzed as area under the curve (AUC) of participant's scores from each assessment in Period III.
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Pfizer Investigational Site
Huntsville, Alabama, United States
Pfizer Investigational Site
Peoria, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Huntington Beach, California, United States
Pfizer Investigational Site
Long Beach, California, United States
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Orange, California, United States
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Paramount, California, United States
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Stockton, California, United States
Pfizer Investigational Site
Tustin, California, United States
...and 114 more locations
Time frame: Period III
Physician's Global Assessment of Arthritis at Final Visit
Physician assessed each participant's disease symptoms on a categorical scale from 1 (very good) to 5 (very poor).
Time frame: Period III (22 weeks)
Total Rescue Medication Taken (Mean)
Total amount of rescue medication (acetaminophen in milligrams \[mg\]) taken per month per participant
Time frame: Period III (22 weeks)
Proportion of Days on Rescue Medication
Days on rescue medication divided by number of days on study medication in Period III
Time frame: Period III (22 weeks)
Days on Flare Medication
Number of days on flare medication per month per subject calculated as number of days on flare medication divided by the number of days on study medication in Period III
Time frame: Period III (22 weeks)
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
Score at end of Period III minus score at start of Period III. WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Negative change indicates improvement.
Time frame: Period III (22 weeks)
Area Under the Curve (AUCs) of Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Scores
WOMAC assesses subject responses to 24 components regarding subscales of pain, stiffness and physical function (score range: 0=none to 4= extreme). Total score is sum of the 3 subscale scores. Scores analyzed as area under the curve (AUC) of participant's WOMAC scores from each assessment in Period III.
Time frame: Period III (22 weeks)