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To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| C | Placebo Comparator |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | 800 mg oral tablet 3 times daily with meals for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in patient's assessment of arthritis pain according to visual analogue scale | Week 6 |
| 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 |
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Inclusion Criteria:
Inclusion criteria:
Exclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Bad Münder am Deister | 31848 | Germany | |||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28222627 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo |
| Drug |
Matched placebo orally for 6 weeks |
|
| Celecoxib | Drug | 200 mg oral capsule once daily with morning meal for 6 weeks |
|
| 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 |
| Beckum |
| 59269 |
| Germany |
| Pfizer Investigational Site | Berlin | 10435 | Germany |
| Pfizer Investigational Site | Berlin | 10559 | Germany |
| Pfizer Investigational Site | Berlin | 12687 | Germany |
| Pfizer Investigational Site | Berlin | 13125 | Germany |
| Pfizer Investigational Site | Ostseebad Damp | 24351 | Germany |
| Pfizer Investigational Site | Schwerin | 19057 | Germany |
| Pfizer Investigational Site | Stade | 21680 | Germany |
| Pfizer Investigational Site | Tostedt | 21255 | Germany |
| Pfizer Investigational Site | Weener | 26826 | Germany |
| Pfizer Investigational Site | Barcelona | 08029 | Spain |
| Pfizer Investigational Site | Barcelona | 08036 | Spain |
| Pfizer Investigational Site | Cadiz | 11009 | Spain |
| Pfizer Investigational Site | Guadalajara | 19002 | Spain |
| Pfizer Investigational Site | Madrid | 28035 | Spain |
| Pfizer Investigational Site | Madrid | 28040 | Spain |
| Pfizer Investigational Site | Madrid | 28046 | Spain |
| Pfizer Investigational Site | Oviedo | 33006 | Spain |
| Pfizer Investigational Site | Seville | 41014 | Spain |
| Pfizer Investigational Site | Valencia | 46009 | Spain |
| Pfizer Investigational Site | Chelmsly WOOD | Birmingham | B37 7TR | United Kingdom |
| Pfizer Investigational Site | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Pfizer Investigational Site | Chorley | Lancs | PR7 1NY | United Kingdom |
| Pfizer Investigational Site | Liverpool | Lancs | L1 9AD | United Kingdom |
| Pfizer Investigational Site | Cannock | Mid Staffordshire | WS11 2XY | United Kingdom |
| Pfizer Investigational Site | Addlestone | Surrey | KT15 2BH | United Kingdom |
| Pfizer Investigational Site | Huddersfield | HD3 3EA | United Kingdom |
| Pfizer Investigational Site | London | NW3 2PF | United Kingdom |
| Pfizer Investigational Site | London | SE5 9RS | United Kingdom |
| Pfizer Investigational Site | Manchester | M41 5SL | United Kingdom |
| Pfizer Investigational Site | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Pfizer Investigational Site | Wigan | WN6 9EW | United Kingdom |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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