Clinical trial NCT00630929: Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-07
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 ibuprofen in subjects with osteoarthritis (OA) of the knee.


Eligibility criteria: Inclusion 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:

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

Primary outcomes:
measure: Change from baseline in patient's assessment of arthritis pain according to visual analogue scale
timeFrame: Week 6
Secondary outcomes:
measure: Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores
timeFrame: Days 1-7
measure: Change from baseline in patient's assessment of arthritis pain according to visual analogue scale
timeFrame: Week 2
measure: Change from baseline in patient and physician global assessments of arthritis
timeFrame: Weeks 2 and 6
measure: Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: Week 6
measure: The Pain Satisfaction Scale
timeFrame: Week 6
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: Week 6
measure: Measurement of upper gastrointestinal tolerability
timeFrame: Weeks 2 and 6
measure: Adverse events
timeFrame: Weeks 2 and 6
measure: Laboratory test results
timeFrame: Week 6
measure: Vital signs
timeFrame: Weeks 2 and 6
measure: Physical examination
timeFrame: Week 6
Other outcomes:
Locations:
city: Bad Muender
country: Germany
facility: Pfizer Investigational Site
city: Beckum
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Ostseebad Damp
country: Germany
facility: Pfizer Investigational Site
city: Schwerin
country: Germany
facility: Pfizer Investigational Site
city: Stade
country: Germany
facility: Pfizer Investigational Site
city: Tostedt
country: Germany
facility: Pfizer Investigational Site
city: Weener
country: Germany
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Cadiz
country: Spain
facility: Pfizer Investigational Site
city: Guadalajara
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Oviedo
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Chelmsly WOOD
country: United Kingdom
facility: Pfizer Investigational Site
state: Birmingham
city: Truro
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Chorley
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancs
city: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancs
city: Cannock
country: United Kingdom
facility: Pfizer Investigational Site
state: Mid Staffordshire
city: Addlestone
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Huddersfield
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Pfizer Investigational Site
city: Wigan
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Gordo AC, Walker C, Armada B, Zhou D. Efficacy of celecoxib versus ibuprofen for the treatment of patients with osteoarthritis of the knee: A randomized double-blind, non-inferiority trial. J Int Med Res. 2017 Feb;45(1):59-74. doi: 10.1177/0300060516673707. Epub 2017 Jan 12.