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

Study Overview
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Brief Summary
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To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.

Official Title
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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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Placebo
* Drug: Celecoxib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Ibuprofen<br>* 800 mg oral tablet 3 times daily with meals for 6 weeks<br>|
| Placebo Comparator: C<br> | Drug: Placebo<br>* Matched placebo orally for 6 weeks<br>|
| Experimental: B<br> | Drug: Celecoxib<br>* 200 mg oral capsule once daily with morning meal for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in patient's assessment of arthritis pain according to visual analogue scale |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores |  | Days 1-7 | 
| Change from baseline in patient's assessment of arthritis pain according to visual analogue scale |  | Week 2 | 
| Change from baseline in patient and physician global assessments of arthritis |  | Weeks 2 and 6 | 
| Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index |  | Week 6 | 
| The Pain Satisfaction Scale |  | Week 6 | 
| The Patient Health Questionnaire (PHQ-9) |  | Week 6 | 
| Measurement of upper gastrointestinal tolerability |  | Weeks 2 and 6 | 
| Adverse events |  | Weeks 2 and 6 | 
| Laboratory test results |  | Week 6 | 
| Vital signs |  | Weeks 2 and 6 | 
| Physical examination |  | Week 6 |