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A randomized placebo-controlled trial comparing the efficacy of etoricoxib 30 mg and ibuprofen 2400 mg for the treatment of patients with osteoarthritis . OBJECTIVE We compared the efficacy of etoricoxib 30 mg to placebo and ibuprofen 2400 mg for the treatment of osteoarthritis ( OA ) of the hip and knee . DESIGN In this 12-week , randomized , double-blind , placebo- and active-comparator-controlled trial , 548 patients ( median age 63 years ) with OA of the hip or knee were randomized to receive placebo , etoricoxib 30 mg q.d. , or ibuprofen 800 mg t.i.d . Demonstration of etoricoxib 's efficacy vs placebo and comparison of its efficacy to ibuprofen were assessed using three co-primary endpoints : Western Ontario and McMaster 's University Osteoarthritis Index ( WOMAC ) Pain Subscale ( WOMAC-PS ) ; WOMAC Physical Function Subscale ( WOMAC-PFS ) ; and Patient Global Assessment of Disease Status ( PGADS ) . Each primary endpoint utilizes a 0-100 mm visual analog scale . To demonstrate comparable efficacy of etoricoxib vs ibuprofen , the 95 % confidence intervals ( CIs ) for the difference in the least squares ( LS ) mean change over 12 weeks for all three co-primary endpoints had to fall within +/-10 mm . Safety and tolerability data were collected throughout the study . RESULTS Mean baseline values for the three co-primary endpoints ranged from 62.52 to 70.14 mm . Both etoricoxib and ibuprofen demonstrated superior ( P < or =0.002 ) efficacy for all primary endpoints . The LS mean ( mm ) changes ( 95 % CI ) over 12 weeks for etoricoxib and ibuprofen , respectively , compared to placebo were given as follows : WOMAC-PS : -11.66 ( -16.31 , -7.01 ) and -7.62 ( -12.30 , -2.94 ) ; WOMAC-PFS : -10.15 ( -14.74 , -5.57 ) and -7.23 ( -11.85 , -2.61 ) ; PGADS : -11.65 ( -16.81 , -6.50 ) and -8.11 ( -13.30 , -2.92 ) . The efficacy of etoricoxib 30 mg was comparable to ibuprofen 2400 mg. All treatments were similarly well tolerated . CONCLUSION Treatment with etoricoxib 30 mg q.d . provides superior efficacy vs placebo and comparable clinical efficacy vs ibuprofen 2400 mg ( 800 mg t.i.d . ) for the treatment of OA of the hip and knee .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
etoricoxib
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Intervention_Pharmacological
ibuprofen
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Intervention_Pharmacological
etoricoxib
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Intervention_Control
placebo
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Intervention_Pharmacological
ibuprofen
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Intervention_Control
placebo-
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Intervention_Control
placebo
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Intervention_Pharmacological
etoricoxib
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Intervention_Pharmacological
ibuprofen
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Intervention_Pharmacological
etoricoxib 's
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Intervention_Control
placebo
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Intervention_Pharmacological
ibuprofen
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Intervention_Pharmacological
etoricoxib
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Intervention_Pharmacological
ibuprofen
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Intervention_Pharmacological
etoricoxib
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Intervention_Pharmacological
ibuprofen
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Intervention_Pharmacological
etoricoxib
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Intervention_Pharmacological
ibuprofen
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Intervention_Control
placebo
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Intervention_Pharmacological
etoricoxib
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Intervention_Pharmacological
ibuprofen
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Intervention_Pharmacological
etoricoxib
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Intervention_Control
placebo
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Intervention_Pharmacological
ibuprofen
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Outcome_Pain
Western Ontario and McMaster 's University Osteoarthritis Index ( WOMAC ) Pain Subscale ( WOMAC-PS )
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Outcome_Physical
WOMAC Physical Function Subscale ( WOMAC-PFS )
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Outcome_Physical
Patient Global Assessment of Disease Status ( PGADS )
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Outcome_Physical
least squares ( LS ) mean change
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Outcome_Physical
Safety and tolerability
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Outcome_Other
data
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Outcome_Physical
Mean baseline values
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Outcome_Other
efficacy
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Outcome_Pain
WOMAC-PS
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Outcome_Physical
WOMAC-PFS
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Outcome_Physical
PGADS
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Outcome_Other
efficacy
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Outcome_Other
tolerated
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Outcome_Other
efficacy
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Participant_Condition
osteoarthritis
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Participant_Condition
osteoarthritis ( OA ) of the hip and knee
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Participant_Sample-size
548 patients
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Participant_Condition
OA of the hip or knee
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Participant_Condition
OA of the hip and knee